Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00411086|
Recruitment Status : Completed
First Posted : December 13, 2006
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
RATIONALE: 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma.
PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: Rituximab Biological: Sargramostim (GM-CSF)||Phase 2|
- Determine the safety and efficacy of rituximab and sargramostim (GM-CSF), in terms of complete response at 12 weeks, in patients with newly diagnosed follicular B-cell lymphoma.
- Determine the overall response rate in patients treated with this regimen.
- Determine the progression-free survival at 3 years in patients treated with this regimen.
- Determine the adverse event profile of this regimen in these patients.
- Determine the survival of patients treated with this regimen.
- Determine the effect of Fc gamma receptor polymorphism on response rate and time to progression in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV on days 1, 8, 15, and 22 and sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5. Treatment with GM-CSF repeats weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma receptor RIIIa 158 polymorphism.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Rituximab + GM-CSF
Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22.
Other Name: RituxanBiological: Sargramostim (GM-CSF)
250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
- Complete Response Rate [ Time Frame: 12 weeks (3 months) ]
Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities [e.g., lactate dehydrogenase (LDH)] definitely assignable to NHL.
Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
- Median Progression-Free Survival (PFS) [ Time Frame: 3 years ]PFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS.
- Overall Response (OR) Rate [ Time Frame: 3 Months ]OS defined as percentage of participants alive at a certain period following start of chemotherapy treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411086
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Nathan Fowler, MD||M.D. Anderson Cancer Center|