Lymphoma, Non-Hodgkin
Conditions
Keywords
Tositumomab, radioimmunotherapy, rituximab, anti-B1, I 131, Bexxar, iodine, non-Hodgkin's lymphoma
Brief summary
This is a single-arm, open-label, multicenter study of Iodine I-131 Anti B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) for treatment of non-Hodgkin's lymphoma (NHL) who were previously treated with rituximab antibody. Patients must have been treated with at least 4 doses of rituximab and have progressed during or following rituximab therapy. Patients will undergo two dosing phases of study. In the first phase, termed the dosimetric dose, patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70 minutes immediately followed by a 30-minute infusion of Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from three imaging timepoints, a patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose of radiotherapy. In the second phase, termed the therapeutic dose, patients will receive a 70-minute infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion of 35 mg Anti-B1 Antibody labeled with a patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy to patients with no hematologic risk factors. Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean body mass. Patients will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose). The endpoints of the study are to determine the response rate, complete response rate, duration of response, and time to progression or death, based on both a Masked Independent Randomized Radiographic and Oncologic Review (MIRROR) panel and the Investigators, and the Investigators' assessment of safety and survival of survival of Iodine-131 Anti-B1 Antibody therapy in NHL patients who have previously been treated with rituximab.
Interventions
BIOLOGICALAnti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab)
Patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of Anti-B1 Antibody (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Patients will then receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of 35 mg Anti-B1 Antibody containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation. * Patients must have evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1 Antibody or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20 positivity. * Patients must have been treated with at least 4 doses of rituximab at any time and failed to achieve an objective response (CR, CCR, PR) or relapse/progressed during treatment or following the completion of rituximab therapy. * Patients must have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least 3 months. * Patients must have an absolute granulocyte count \>1500 cells/mm3 (US) and a platelet count \>100,000 cells/mm3 (US) within 14 days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products. * Patients must have adequate renal function (defined as serum creatinine \<1.5 x upper limit of normal \[ULN\]) and hepatic function (defined as total bilirubin \<1.5 x ULN and aspartate transaminase \[AST\] \<5 x ULN) within 14 days of study entry. * Patients must have bi-dimensionally measurable disease. At least one lesion must be greater than or equal to 2 x 2 cm (by computed tomography \[CT\] scan). * Patients must be at least 18 years of age. * Patients must give written informed consent and sign an IRB/EC- approved informed consent form prior to study entry.
Exclusion criteria
* Patients with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%. * Patients who received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (6 weeks of nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids must be discontinued at least 1 week prior to study entry. * Patients with prior hematopoietic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy. * Patients with active obstructive hydronephrosis. * Patients with evidence of active infection requiring intravenous (IV) antibiotics at the time of study entry. * Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation. * Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. * Patients with known HIV infection. * Patients with known brain or leptomeningeal metastases. * Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy. * Patients with previous allergic reactions to iodine. This does not include reacting to IV iodine-containing contrast materials. * Patients who previously received radioimmunotherapy. * Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with \> 3500 cGy. * Patients who are HAMA positive. * Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Overall survival is defined as the time from the treatment start date to the date of death from any cause. |
| Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Response duration is defined as the time from the first documented response until disease progression. |
| Duration of Response for Confirmed CR as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be \>2 centimeters (cm) in diameter by radiographic evaluation or \>1 cm in diameter by physical examination. |
| Duration of Response for CR and CCR as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Response duration is defined as the time from the first documented response until disease progression. |
| Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Response duration is defined as the time from the first documented response until progressive disease. |
| Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507. |
| Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Duration of response is defined as the time from the first documented response to disease progression. |
| Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. |
| Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Duration of response is defined as the time from the first documented response to disease progression. |
| Progression-free Survival for Participants With or Without a Prior Response to Rituximab | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death. |
| Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. |
| Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). |
| Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. |
| Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =\<2 centimeters (cm) in diameter by radiographic evaluation or =\<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR. |
| Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Confirmed PR is defined as a \>=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Type of Infection | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required. |
| Number of Participants With an Infection for Which Anti-infectives Were Administered | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals. |
| Number of Participants With Serious Adverse Events (SAE) Related to Study Drug | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement. |
| Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values. |
| Nadir Values for ANC, a Hematologic Parameter | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection. |
| Nadir Values for Hemoglobin, a Hematologic Parameter | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells. |
| Nadir Values for Hematologic Parameters Platelets and WBC Count | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells. |
| Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. |
| Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. |
| Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug. |
Participant flow
Pre-assignment details
Participants received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases: Phase 1, dosimetric dose; Phase 2, therapeutic dose. After radioimmunotherapy, participants could have entered a 10-year Long-Term Follow-Up study (Study BEX104526; NCT00240591) for continued evaluation.
Participants by arm
| Arm | Count |
|---|---|
| TST and Iodine I 131 TST Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray \[cGy\] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Dosimetric and Therapeutic Treatment | Death | 1 |
| Dosimetric and Therapeutic Treatment | Did Not Receive Any Study Drug | 3 |
| Dosimetric and Therapeutic Treatment | Enrolled in BEX104526 | 6 |
| Dosimetric and Therapeutic Treatment | Lost to Follow-up | 7 |
| Dosimetric and Therapeutic Treatment | Non-compliance | 1 |
| Dosimetric and Therapeutic Treatment | Progressive Disease | 22 |
| Dosimetric and Therapeutic Treatment | Withdrawal by Subject | 3 |
| Long-Term Follow-Up | Site Closed | 1 |
| Long-Term Follow-Up | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | TST and Iodine I 131 TST |
|---|---|
| Age, Continuous | 57.0 Years STANDARD_DEVIATION 11.8 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black | 3 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants |
| Race/Ethnicity, Customized White | 33 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 40 |
| serious Total, serious adverse events | 13 / 40 |
Outcome results
Primary
Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator
Response duration is defined as the time from the first documented response until progressive disease.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TST and Iodine I 131 TST | Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator | 8.8 months |
Primary
Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator
Response duration is defined as the time from the first documented response until disease progression.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TST and Iodine I 131 TST | Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator | 22.2 months |
Primary
Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab
Duration of response is defined as the time from the first documented response to disease progression.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with a response were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TST and Iodine I 131 TST | Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab | Responders with prior response to Rituximab; n=12 | 18.6 months |
| TST and Iodine I 131 TST | Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab | Responders w/o prior response to Rituximab; n=16 | 19.2 months |
p-value: 0.8Fisher Exact
Primary
Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab
Duration of response is defined as the time from the first documented response to disease progression.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TST and Iodine I 131 TST | Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab | Responders with prior response to Rituximab; n=5 | 47.3 months |
| TST and Iodine I 131 TST | Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab | Responders w/o prior response to Rituximab; n=4 | NA months |
p-value: 0.2Fisher Exact
Primary
Duration of Response for Confirmed CR as Assessed by the Investigator
Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be \>2 centimeters (cm) in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants with confirmed CR and those who experienced progressive disease were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TST and Iodine I 131 TST | Duration of Response for Confirmed CR as Assessed by the Investigator | NA months |
Primary
Duration of Response for CR and CCR as Assessed by the Investigator
Response duration is defined as the time from the first documented response until disease progression.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants with confirmed CR + CCR response and those who experienced progressive disease were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TST and Iodine I 131 TST | Duration of Response for CR and CCR as Assessed by the Investigator | NA months |
Primary
Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator
Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TST and Iodine I 131 TST | Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator | 26 participants |
95% CI: [50, 80]
Primary
Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator
CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator | 9 participants |
95% CI: [10, 35]
Primary
Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator
CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =\<2 centimeters (cm) in diameter by radiographic evaluation or =\<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator | 15 participants |
95% CI: [22, 53]
Primary
Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator
Confirmed PR is defined as a \>=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator | 11 participants |
95% CI: [14, 41]
Primary
Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study
CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study | Responders with prior response to Rituximab; n=16 | 5 participants |
| TST and Iodine I 131 TST | Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study | Responders w/o prior response to Rituximab; n=24 | 4 participants |
p-value: 195% CI: [9, 54]Fisher Exact
p-value: 195% CI: [2, 33]Fisher Exact
Primary
Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study
Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study | Responders with prior response to Rituximab; n=16 | 12 participants |
| TST and Iodine I 131 TST | Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study | Responders w/o prior response to Rituximab; n=24 | 16 participants |
p-value: 195% CI: [54, 96]Fisher Exact
p-value: 195% CI: [51, 88]Fisher Exact
Primary
Overall Survival
Overall survival is defined as the time from the treatment start date to the date of death from any cause.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TST and Iodine I 131 TST | Overall Survival | 80 months |
Primary
Progression-free Survival for Participants With or Without a Prior Response to Rituximab
Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TST and Iodine I 131 TST | Progression-free Survival for Participants With or Without a Prior Response to Rituximab | Responders with prior response to Rituximab; n=5 | 13.0 months |
| TST and Iodine I 131 TST | Progression-free Survival for Participants With or Without a Prior Response to Rituximab | Responders w/o prior response to Rituximab; n=4 | 8.9 months |
p-value: 0.9Log Rank
Primary
Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator
Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants who experienced progression were evaluated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TST and Iodine I 131 TST | Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator | All responders, n=30 | 10.4 months |
| TST and Iodine I 131 TST | Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator | CR + CCR, n=15 | NA months |
| TST and Iodine I 131 TST | Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator | PR, n=11 | 9.2 months |
Secondary
Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities
Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TST and Iodine I 131 TST | Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities | ANC, n=16 | 14 days |
| TST and Iodine I 131 TST | Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Hemoglobin, n=5 | 28 days |
| TST and Iodine I 131 TST | Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Platelets, n=10 | 25 days |
| TST and Iodine I 131 TST | Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities | WBC count, n=15 | 11 days |
Secondary
Nadir Values for ANC, a Hematologic Parameter
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TST and Iodine I 131 TST | Nadir Values for ANC, a Hematologic Parameter | 1.2 cells/millimeters cubed (mm^3) |
Secondary
Nadir Values for Hematologic Parameters Platelets and WBC Count
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TST and Iodine I 131 TST | Nadir Values for Hematologic Parameters Platelets and WBC Count | Platelets (10000 cells/microliter) | 84.5 cells/microliter |
| TST and Iodine I 131 TST | Nadir Values for Hematologic Parameters Platelets and WBC Count | WBC count (1000 cells/microliter) | 2.3 cells/microliter |
Secondary
Nadir Values for Hemoglobin, a Hematologic Parameter
Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TST and Iodine I 131 TST | Nadir Values for Hemoglobin, a Hematologic Parameter | 11 G/dL |
Secondary
Number of Participants With an Infection for Which Anti-infectives Were Administered
Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With an Infection for Which Anti-infectives Were Administered | Anti-infective Administered | 19 participants |
| TST and Iodine I 131 TST | Number of Participants With an Infection for Which Anti-infectives Were Administered | Anti-infective Not Administered | 3 participants |
Secondary
Number of Participants With Serious Adverse Events (SAE) Related to Study Drug
An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population. All participants who experienced any SAE were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With Serious Adverse Events (SAE) Related to Study Drug | Myelodysplastic syndrome/Acute myeloid leukemia | 2 participants |
| TST and Iodine I 131 TST | Number of Participants With Serious Adverse Events (SAE) Related to Study Drug | Malignant hepatobiliary neoplasm | 1 participants |
| TST and Iodine I 131 TST | Number of Participants With Serious Adverse Events (SAE) Related to Study Drug | Squamous cell carcinoma | 1 participants |
| TST and Iodine I 131 TST | Number of Participants With Serious Adverse Events (SAE) Related to Study Drug | Tumor lysis syndrome | 1 participants |
| TST and Iodine I 131 TST | Number of Participants With Serious Adverse Events (SAE) Related to Study Drug | Pyrexia | 1 participants |
| TST and Iodine I 131 TST | Number of Participants With Serious Adverse Events (SAE) Related to Study Drug | Anemia | 1 participants |
Secondary
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Productive Cough | 2 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Absolute Neutrophil Count (ANC) <1000 cells/cm^3 | 16 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | White Blood Cells (WBC) <2000 cells/cm^3 | 15 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Platelets <50000 cells/cm^3 | 10 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Hemoglobin <8.0 grams/deciliter (g/dL) | 5 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Pyrexia | 9 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Fatigue | 7 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Chills | 4 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Edema Peripheral | 3 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Asthenia | 2 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Malaise | 2 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Arthralgia | 5 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Myalgia | 3 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Nausea | 7 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Vomiting | 5 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Anaemia | 4 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Thrombocytopenia | 3 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Neutropenia | 2 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Pruritus | 3 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Rash | 3 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Epistaxis | 3 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Decreased Appetite | 2 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Upper Respiratory Tract Infection | 3 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Myelodysplastic Syndrome/ Acute Myeloid Leukemia | 2 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants | Headache | 3 participants |
Secondary
Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities
Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities | ANC | 16 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Hemoglobin | 5 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities | Platelets | 10 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities | WBC count | 15 participants |
Secondary
Number of Participants With the Indicated Type of Infection
An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Any Infection; n=40 | 22 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | No Infection; n=40 | 18 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Meningitis; n=22 | 0 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Pyelonephritis; n=22 | 0 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Sepsis; n=22 | 1 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Pneumonia; n=22 | 5 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Endocarditis/ Pericarditis; n=22 | 0 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Peritonitis; n=22 | 0 participants |
| TST and Iodine I 131 TST | Number of Participants With the Indicated Type of Infection | Other Infections; n=22 | 17 participants |
Secondary
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations
Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.
Time frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Population: ITT Exposed Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to nadir ANC, n=40 | 43.5 days |
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to nadir hemoglobin, n=40 | 43 days |
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to nadir platelets, n=40 | 34.5 days |
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to nadir WBC count, n=40 | 43 days |
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to recovery to baseline ANC, n=32 | 71 days |
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to recovery to baseline hemoglobin, n=29 | 74 days |
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to recovery to baseline platelets, n=29 | 55 days |
| TST and Iodine I 131 TST | Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations | Time to recovery to baseline WBC count, n=28 | 78 days |