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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Astex Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00541034
First received: October 5, 2007
Last updated: July 13, 2017
Last verified: July 2017
October 5, 2007
July 13, 2017
May 2005
January 2016   (Final data collection date for primary outcome measure)
Overall Objective Response [ Time Frame: 2 years ]
The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.
  • Complete response
  • Toxicity
Complete list of historical versions of study NCT00541034 on ClinicalTrials.gov Archive Site
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Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Phase II Study of Pentostatin With Cyclophosphamide and Rituximab for Previously Untreated Patients With Chronic Lymphocytic Leukemia

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: pentostatin
Experimental: cyclophosphamide, pentostatin & rituximab
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.
Interventions:
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: pentostatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
January 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00541034
05-051
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-05051
Not Provided
Not Provided
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
  • Astex Pharmaceuticals
Principal Investigator: Nicole Lamanna, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Renier Brentjens, MD, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP