At a glance
ClinicalIndex Comparison Record- ✓One of the following B-cell leukemias or lymphomas: Chronic lymphocytic leukemia/small lymphocytic lymphoma, B-cell prolymphocytic leukemia, lymphoplasmacytic leukemia, marginal zone lymphoma, follicular lymphoma (grade 1 or 2), or mantle cell lymphoma
- ✓No more than approximately 10% morphologically identifiable cancer cells on bone marrow biopsy (or ≤10% by flow cytometry if morphologically difficult to distinguish)
- ✓Must have received ≤12 months of prior cytotoxic therapy with at least partial response achieved
- ✓ECOG performance status 0-1
- ✕Active infections requiring oral or intravenous antibiotics
- ✕Known sensitivity to E. coli-derived products (filgrastim, insulin, asparaginase, growth hormone, interferon alfa-2b) or study drugs
- ✕Other second malignancy except basal/squamous cell carcinoma of skin or cervical carcinoma in situ (unless previously treated with >90% probability of cure)
- ✕Concurrent steroids during rituximab administration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Pegfilgrastim, Rituximab, and 1 other intervention for Leukemia and Lymphoma. Completed, enrolled 94 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
6 mg SQ 24-48 hours after last dose of cyclophosphamide.
375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
50 mg/kg/day on Days 15, 16, 17, and 18.