Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study ID
- NCT00278161
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pegfilgrastim — BIOLOGICAL6 mg SQ 24-48 hours after last dose of cyclophosphamide.
- Rituximab — BIOLOGICAL375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
- Cyclophosphamide — DRUG50 mg/kg/day on Days 15, 16, 17, and 18.
Study Details
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.
Key Dates
- Start date
- Jan 31, 2005
- Status verified
- Oct 2018
- Primary completion
- Dec 31, 2009
- Completion
- Jul 31, 2011
Study Design
- Enrollment
- 94 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: R-HiCyRituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Primary Outcome Measure
Engraftment [ Time Frame: Up to 43 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | - |
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