Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00278161|
Recruitment Status : Completed
First Posted : January 18, 2006
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: Pegfilgrastim Biological: Rituximab Drug: Cyclophosphamide||Phase 2|
- Determine the safety of high-dose cyclophosphamide, rituximab, and pegfilgrastim in patients with B-cell leukemia or low-grade or mantle cell lymphoma.
- Determine the molecular response rate in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive rituximab IV over 30-60 minutes on days 1, 4, 8,11, 45, and 52, cyclophosphamide IV over 1 hour on days 15-18, and pegfilgrastim subcutaneously on day 19 or 20 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||July 2011|
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Other Name: Neulasta
375 mg/m^2/day on Days 1, 4, 8, 11, 45, and 52.
Other Name: Rituxan
50 mg/kg/day on Days 15, 16, 17, and 18.
- Engraftment [ Time Frame: Up to 43 days ]Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count >= 500 cells per microliter; platelet recovery is defined as untransfused platelet count >= 20 * 10^9 cells per liter.
- Non-relapse Mortality [ Time Frame: 5 years ]Number of participants who died for reasons related to protocol treatment.
- Event-free Survival [ Time Frame: 5 years ]Percentage of participants alive without disease relapse.
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): NCT00278161
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Lode J. Swinnen, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|