GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologic diagnosis of grade 1, 2, 3, or transformed follicular lymphoma
Achieved a complete or partial response to last salvage therapy
- Completed salvage therapy within the past 12 weeks
- No disease progression since last salvage therapy
One of the following disease statuses must have been present prior to receiving salvage therapy
- Refractory to last anti-lymphoma therapy
- Last remission duration less than 1½ years if salvage therapy is 3rd regimen
- Last remission duration less than 3 years if salvage therapy is 2nd regimen
- Minimum of 2 x 10^6 CD34+ cells/kg cryopreserved and available for hematopoietic stem cell support
- No leptomeningeal disease or brain parenchyma involvement
PATIENT CHARACTERISTICS:
Cardiac ejection fraction > 50%
- If over 60 years of age, no evidence of cardiac ischemia by treadmill stress test (stress echo or sesta-MIBI)
- Adjusted diffusing capacity ≥ 50% of the predicted value on pulmonary function testing
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mL/min
- ANC > 1,000/μL
- Platelet count > 50,000/μL
- Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert's disease is suspected)
- Not pregnant or breast-feeding
- Fertile patients must use an acceptable form of birth control
- HIV I or II negative
- No acute or chronic hepatitis B
- No active hepatitis C
- No medical illness (unrelated to non-Hodgkin lymphoma), including malignancies that, in the opinion of the attending physician and/or principal investigator, would preclude study treatment
- No other malignancy within the past 5 years except curatively treated cutaneous basal cell or squamous cell carcinoma or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
No more than 3 prior anti-lymphoma regimens, inclusive of the salvage therapy
- Biologic agents (e.g., monoclonal antibodies and vaccines) administered as part of a planned treatment regimen will not be considered distinct regimens
- Chemotherapy administered primarily for the purpose of stem cell mobilization (e.g., cyclophosphamide at 2-4 g/m²) will not be considered an anti-lymphoma regimen
- No prior autologous or allogeneic hematopoietic stem cell transplantation
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
GM-CSF and Rituximab After Autologous Stem Cell Transplant
GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, administered on alternate days. Thus, 24 doses of GM-CSF will be administered. Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF; rituximab. The second course of GM-CSF and rituximab will be administered approximately 22-26 weeks (day +154 to +182) after ASCT.