Cyclophosphamide, Alvocidib, and Rituximab in Treating Patients With High Risk B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Stopped early · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT01076556
- Run by
- National Cancer Institute (NCI)
- People needed
- 9
- Starts
- 2010-04-01
- Last updated by the study team
- 2015-11-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed chronic lymphocytic leukemia (CLL) or B-cell prolymphocytic leukemia* (PLL) arising from CLL
- Patients must have documented B-cell lymphocytosis > 5 x 10\^9/L at some point since initial diagnosis of CLL
- Patients must have B-cells that co-express CD5 with CD19 or CD20
- Patients who do not have dim sIg or CD23 expression on their leukemia cells should be examined for cyclin D1 over-expression or t(11;14) to rule out mantle cell lymphoma
- To be considered high risk, patients must meet the following criteria:
- At least 1 of the following:
- 17p deletion
- 11q deletion
- Un-mutated IgV_H (≥ 98% homology)
- Age > 70 years
- B_2M > 4
- AND at least 1 of the following:
- Progressive or marked splenomegaly and/or lymphadenopathy
- Anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelets < 100,000/mm\^3)
- Weight loss exceeding 10% of body weight over preceding 6 months
- NCI grade 2 or 3 fatigue
- Fevers > 100.5° F or night sweats for > 2 weeks without evidence of infection
- Progressive lymphocytosis, with an increase exceeding 50% over a 2-month period or a doubling time of < 6 months
- No other concurrent hormones, chemotherapy, or radiotherapy except for steroids for new adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
- No requirement for chronic corticosteroids
- ECOG performance status 0-2
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 1.5 times normal unless due to Gilbert disease, hemolysis, or disease infiltration of the liver
- AST ≤ 2 times normal unless due to hemolysis or disease infiltration of the liver
- Negative pregnancy test
Where it is running
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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