Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer
Part of paid clinical trials in New York, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT00546377
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Not accepted
Interventions
- filgrastim — BIOLOGICAL
- pegfilgrastim — BIOLOGICAL
- rituximab — BIOLOGICAL
- sargramostim — BIOLOGICAL
- cyclophosphamide — DRUG
- mitoxantrone hydrochloride — DRUG
- pentostatin — DRUG
- fluorescence in situ hybridization — GENETIC
- gene rearrangement analysis — GENETIC
- polymerase chain reaction — GENETIC
- protein expression analysis — GENETIC
- flow cytometry — OTHER
- biopsy — PROCEDURE
Study Details
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving pentostatin together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell cancer.
Key Dates
- Start date
- Jul 31, 2005
- Status verified
- Apr 2016
- Primary completion
- May 31, 2014
- Completion
- May 31, 2014
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Mitoxantrone
Primary Outcome Measure
Overall Response [ Time Frame: 3 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | - |
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