Non-Hodgkin Lymphoma
Conditions
Brief summary
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.
Detailed description
OBJECTIVES: I. Evaluate the efficacy of combining RICE (rituximab-ifosfamide-carboplatin-etoposide regimen \[R-ICE regimen\]), G-CSF, and plerixafor to collect autologous peripheral blood stem cell (PBSC) for non-Hodgkin's lymphoma (NHL) patients by: the number of days of apheresis required to reach \>= 5 x 10\^6 cluster of differentiation (CD)34 cells/kg and by the total number of CD34 cells/kg collected in a maximum of 4 days if \>= 5 x 10\^6 CD34 cells/kg is not obtained. OUTLINE: Patients receive rituximab intravenously (IV) on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive filgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected. After completion of study treatment, patients are followed up at 30 days and then periodically for up to 12 months.
Interventions
DRUGCarboplatin
Given IV
DRUGEtoposide
Given IV
BIOLOGICALFilgrastim
Given SC
DRUGIfosfamide
Given IV
PROCEDURELeukapheresis
Given through catheter
DRUGPlerixafor
Given SC
BIOLOGICALRituximab
Given IV
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
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
* Diagnosis of CD20+ non-Hodgkin's lymphoma * Left ventricular ejection fraction at rest \>= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram * Bilirubin =\< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 times the upper limit of normal * Creatinine clearance (calculated creatinine clearance is permitted) \> 50 mL/min * Signed informed consent * Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)
Exclusion criteria
* Karnofsky performance score \< 70% * Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement) * Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent \> 5 years previously will be allowed * Pregnant or breastfeeding * Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization * Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT) * Human immunodeficiency virus (HIV) positive * Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study * Hepatitis B carriers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) | One Month | Number of patients who achieved ≥5 x 10\^6 CD34 cells/kg autologous PBSC collection by apheresis. |
| Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days | Up to Four Apheresis Days | Number of patients to collect at least 5 x 10\^6 CD34 cells/kg in under 4 apheresis procedures. |
| Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg | Up to Four Apheresis Days | Number of participants requiring one or two apheresis collection days to reach collection goal. |
| Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days | Up to Four Apheresis Days | Number of participants who did not collect ≥5 x 10\^6 CD34 cells/kg in up to four apheresis days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Carboplatin: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Ifosfamide: Given IV
Leukapheresis: Given through catheter
Plerixafor: Given SC
Rituximab: Given IV | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 66 Years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 20 |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
Primary
Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
Number of participants requiring one or two apheresis collection days to reach collection goal.
Time frame: Up to Four Apheresis Days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg | One apheresis collection day | 15 Participants |
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg | Two apheresis collection days | 2 Participants |
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg | Three apheresis collection days | 0 Participants |
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg | Four apheresis collection days | 0 Participants |
Primary
Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)
Number of patients who achieved ≥5 x 10\^6 CD34 cells/kg autologous PBSC collection by apheresis.
Time frame: One Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) | 17 Participants |
Primary
Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days
Number of patients to collect at least 5 x 10\^6 CD34 cells/kg in under 4 apheresis procedures.
Time frame: Up to Four Apheresis Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days | 17 Participants |
Primary
Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days
Number of participants who did not collect ≥5 x 10\^6 CD34 cells/kg in up to four apheresis days
Time frame: Up to Four Apheresis Days
Population: Note: No patients were in this category.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days | 0 Participants |