Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Leukemia, Lymphoma

In brief

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, 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 cyclophosphamide and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin together with cyclophosphamide and rituximab works in treating patients with previously untreated chronic lymphocytic leukemia.

Key facts

Study ID

NCT00541034

Run by

Memorial Sloan Kettering Cancer Center

People needed

49

Starts

2005-05-01

Expected to finish

2016-01-01

Last updated by the study team

2017-08-11

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Karnofsky performance status 60-100%
• Total bilirubin ≤ 2.0 mg/dL (patients with Gilbert disease or autoimmune hemolytic anemia should have an evaluation for other causes of hyperbilirubinemia, but if none are found they may be enrolled regardless of serum bilirubin)
• Total creatinine ≤ 2.0 mg/dL OR creatinine clearance > 50 mL/min
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia are eligible for treatment on this protocol regardless of disease stage

You may not qualify if…

• Significant active infections
• Ongoing hepatitis B infection, specifically hepatitis B antigen or surface antigen positivity
• Patients who are hepatitis B antibody positive are eligible for this protocol
• PRIOR CONCURRENT THERAPY:
• Concurrent prednisone allowed provided it is used as brief courses (≤ 7 days) for inflammatory conditions unrelated to CLL
• No prior cytotoxic therapy or rituximab for this cancer
• No concurrent radiotherapy or other chemotherapy

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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