Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

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 leukemia-cll/" >chronic lymphocytic leukemia.

View Full Description

Full Description

OBJECTIVES:

To determine the frequency of response in patients with previously untreated, intermediate- or high-risk B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab.
To characterize the toxicity of this regimen in these patients.

OUTLINE: Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course 1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 3 months for 1 year.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic lymphocytic leukemia (CLL), as evidenced by an absolute lymphocytosis in the blood of at least 5,000 lymphocytes per microliter OR bone marrow lymphocytosis ≥ 30% of all nucleated cells

Previously untreated disease

Meets 1 of the following risk criteria as defined by the three-stage Rai system

Intermediate-risk disease

Must meet the criteria for active disease as defined by the NCI Working Group guidelines including the following:

Weight loss
Fatigue
Fevers
Evidence of progressive marrow failure
Splenomegaly
Progressive lymphadenopathy
Progressive lymphocytosis with a rapid doubling time
High-risk disease
Malignant lymphocytes must demonstrate B-cells via immunophenotypic or immunohistochemical analysis
Patients with small lymphocytic lymphoma (CLL type) are eligible

PATIENT CHARACTERISTICS:

Inclusion criteria:

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

Exclusion criteria:

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

49

Study ID:

NCT00541034

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

49

Study ID:

NCT00541034

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider