Cyclophosphamide, Alvocidib, and Rituximab in Treating Patients With High Risk B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01076556 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2015-11-11
Summary
This phase I trial is studying the side effects and the best dose of alvocidib when given together with cyclophosphamide and rituximab in treating patients with high risk B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. 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. Alvocidib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can also block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Other find cancer cells and help kill them or carry cancer-killing substances to them. Giving cyclophosphamide, alvocidib, and rituximab together may kill more cancer cells.
Conditions
- Chronic Lymphocytic Leukemia
- Prolymphocytic Leukemia
- Recurrent Small Lymphocytic Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Stage I Chronic Lymphocytic Leukemia
- Stage I Small Lymphocytic Lymphoma
- Stage II Chronic Lymphocytic Leukemia
- Stage II Small Lymphocytic Lymphoma
- Stage III Chronic Lymphocytic Leukemia
- Stage III Small Lymphocytic Lymphoma
- Stage IV Chronic Lymphocytic Leukemia
- Stage IV Small Lymphocytic Lymphoma
Interventions
- DRUG
-
Alvocidib Hydrochloride
Given IV
- DRUG
-
Given IV
- OTHER
-
Diagnostic Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Pharmacological Study
Correlative studies
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Joseph Flynn · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2010-07-31
Countries
- United States
Study Locations
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