Lymphoma
Conditions
Keywords
contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma
Brief summary
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab together with rituximab and combination chemotherapy and to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.
Detailed description
OBJECTIVES: * To evaluate the response rate in patients with previously untreated stage II-IV follicular non-Hodgkin lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP) in combination with iodine I 131 tositumomab. * To evaluate the toxicity of this regimen in these patients. * To estimate the 3-year progression-free survival rate in patients treated with this regimen. * To estimate the 5-year progression-free and overall survival rate in patients treated with this regimen. * To assess the safety profile of this regimen in these patients. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive R-CHOP\* comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable disease then proceed to consolidation therapy. NOTE: \*Patients receive R-CHOP in courses 1-4 and CHOP alone in courses 5 and 6. * Consolidation therapy: Within 12 weeks after completion of induction therapy, patients receive tositumomab IV over 1 hour followed by a dosimetric dose of iodine I 131 tositumomab IV over 20 minutes. Patients then undergo whole body gamma camera scans over a 1-week period to determine the rate of total body clearance of radioactivity and the therapeutic dose of iodine I 131 tositumomab. Within 7-14 days after the dosimetric dose, patients receive tositumomab IV over 1 hour followed by a therapeutic dose of iodine I 131 tositumomab IV over 20 minutes. Patients with at least stable disease then proceed to maintenance therapy. * Maintenance therapy: Beginning approximately 1 year after study entry and no more than 28 days after restaging, patients receive rituximab IV every 3 months for up to 4 years (16 courses) in the absence of disease progression or unacceptable toxicity. After completion of maintenance therapy, patients are followed annually for up to 7 years. Patients who do not complete maintenance therapy are followed every 6 months for 2 years and then annually for up to 7 years.
Interventions
BIOLOGICALrituximab
BIOLOGICALtositumomab
DRUGcyclophosphamide
DRUGdoxorubicin
DRUGprednisone
DRUGvincristine
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
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
DISEASE CHARACTERISTICS: * Histologically confirmed\* grade 1, 2, or 3 follicular B-cell non-Hodgkin lymphoma meeting the following criteria: * Bulky stage II or stage III or IV disease * Diffuse large cell component must be \< 25% of the biopsy * Confirmed cluster of differentiation antigen 20 (CD20) antigen-positive disease NOTE: \*Needle aspiration or cytology are not considered adequate for pathology review * Patient must have unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days * Positive biopsy performed \> 42 days but \< 6 months allowed * Previously untreated disease * Bidimensionally measurable disease * No clinical evidence of central nervous system (CNS) involvement by lymphoma PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Cardiac ejection fraction ≥ 45% by multigated acquisition scan (MUGA) or ECHO * No significant cardiac abnormalities * No known HIV positivity * No requirement for continuous supplemental oxygen therapy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission * Not pregnant or nursing * Fertile patients must use effective contraception during and for 12 months after completion of maintenance therapy PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma * No prior solid organ transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 3-year Progression-free Survival (PFS) | 0-3 years | Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year Progression-free Survival | 0-5 years | Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. |
| 5-year Overall Survival | 0-5 years | Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. |
| Response Rate | up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression | Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of the following. Positron emission tomography (PET) must be negative if no pre-treatment PET scan or when the PET was positive before therapy. If the PET scan was negative before therapy, all nodal masses must have regressed. no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. PR is ≥ 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD. In patients with no pre-treatment PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression. | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| R-CHOP+I-131 Tositumomab Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 Prednisone 100 mg PO Days 1-5 Rituximab 375 mg/m2 IV Day 1 Q 21 Days x 6 Cycles
Patients are restaged by CT scan. Unlabeled tositumomab antibody 450 mg IV within 12 after Cycle 6 of CHOP. Dosimetric dose 35 mg IV after infusion of unlabeled tositumomab antibody. Unlabeled tositumomab antibody 450 mg IV 7-14 days after dosimetric dose. Therapeutic dose 35 mg IV after infusion of unlabeled tositumomab antibody. | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Step 1: Induction | Adverse Event | 3 | 0 |
| Step 1: Induction | Ineligible | 2 | 0 |
| Step 1: Induction | No protocol treatment given | 1 | 0 |
| Step 1: Induction | Other reason not protocol specified | 2 | 0 |
| Step 1: Induction | Refusal unrelated to adverse event | 6 | 0 |
| Step 2: Maintenance | Adverse Event | 0 | 10 |
| Step 2: Maintenance | Death | 0 | 2 |
| Step 2: Maintenance | Ineligible | 0 | 2 |
| Step 2: Maintenance | Other reason not protocol specified | 0 | 7 |
| Step 2: Maintenance | Progression/relapse | 0 | 1 |
| Step 2: Maintenance | Refusal unrelated to adverse event | 0 | 8 |
Baseline characteristics
| Characteristic | R-CHOP+I-131 Tositumomab |
|---|---|
| Age, Continuous | 52.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 69 |
| other Total, other adverse events | 84 / 84 | 66 / 69 |
| serious Total, serious adverse events | 0 / 84 | 1 / 69 |
Outcome results
Primary
Percentage of Participants With 3-year Progression-free Survival (PFS)
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.
Time frame: 0-3 years
Population: Eligible and evaluable patients were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Percentage of Participants With 3-year Progression-free Survival (PFS) | 90 percentage of participants |
Secondary
5-year Overall Survival
Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time frame: 0-5 years
Population: Eligible and evaluable patients were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 5-year Overall Survival | 94 percentage of participants |
Secondary
5-year Progression-free Survival
Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression.
Time frame: 0-5 years
Population: Eligible and evaluable patients were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | 5-year Progression-free Survival | 85 percentage of participants |
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression.
Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 25 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Bladder | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 2 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Enteritis (inflammation of the small bowel) | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nasal cavity/paranasal sinus reactions | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 3 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 8 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 6 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 48 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Opportunistic inf associated w/gt=Gr 2 lymphopenia | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic | 2 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 14 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 2 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 17 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pulmonary hypertension | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Restrictive cardiomyopathy | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 4 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Secondary Malignancy-poss rel to cancer Tx | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Wound | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 6 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Valvular heart disease | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vasovagal episode | 0 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vision-blurred vision | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 2 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 2 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 1 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 34 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Enteritis (inflammation of the small bowel) | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Bladder | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Wound | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Mid ear | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 4 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nasal cavity/paranasal sinus reactions | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Opportunistic inf associated w/gt=Gr 2 lymphopenia | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pulmonary hypertension | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Restrictive cardiomyopathy | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Secondary Malignancy-poss rel to cancer Tx | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Valvular heart disease | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vasovagal episode | 1 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vision-blurred vision | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 0 Participants |
| Rituximab Maintenance | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 0 Participants |
Secondary
Response Rate
Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of the following. Positron emission tomography (PET) must be negative if no pre-treatment PET scan or when the PET was positive before therapy. If the PET scan was negative before therapy, all nodal masses must have regressed. no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. PR is ≥ 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD. In patients with no pre-treatment PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time frame: up to 5 years (1 year induction + 4 years maintenance therapy) or time of disease progression
Population: Eligible and evaluable patients were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Response Rate | Complete Response | 61 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Response Rate | Patital Response | 22 Participants |
| R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance | Response Rate | Assessment Inadequate | 1 Participants |