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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00816595 |
RATIONALE: Drugs used in chemotherapy, such as pentostatin and 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 and bevacizumab, 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.
It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Biological: bevacizumab Biological: pegfilgrastim Biological: rituximab Drug: cyclophosphamide Drug: pentostatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab With or Without Concurrent Avastin® for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL) |
Estimated Enrollment: | 104 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and pentostatin IV over 30 minutes and cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
Biological: bevacizumab
Given IV
Biological: pegfilgrastim
Given subcutaneously
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV
Drug: pentostatin
Given IV
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Arm II: Experimental
Patients receive rituximab IV over 2-4 hours on days 1 and 2 of course 1 and on day 1 of courses 2-6 and pentostatin IV over 30 minutes and cyclophosphamide IV over 30 minutes on day 1. Patients also receive pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
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Biological: pegfilgrastim
Given subcutaneously
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV
Drug: pentostatin
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to Rai risk group (high [Rai stage III or IV] vs low [Rai stage 0] or intermediate [Rai stage I or II]) and FISH prognosis group (favorable [normal, +12, 13q-, or other] vs unfavorable [17p- or 11q-]). Patients are randomized to 1 of 2 treatment arms.
Patients also receive pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6.
Treatment repeats every 21 days* for 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Course 6 is 56 days in duration
Patients undergo blood sample collection and bone marrow biopsy/aspiration periodically for translational research studies. Samples are analyzed by flow cytometry for assessment of minimal residual disease. Molecular prognostic markers (including CD38, ZAP-70, IgVH gene mutation status, and cytogenetic abnormalities by FISH), Tcl-1 and CD49d protein expression, and immunoglobulin heavy chain D and J family gene usage are also analyzed.
Plasma samples are stored for future studies evaluating levels of VEGF, bFGF, and thrombospondin by ELISA.
After completion of study therapy, patients are followed periodically for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Chronic lymphocytic leukemia (CLL)* as evidenced by the following criteria:
Immunophenotyping consistent with CLL, defined by the following:
Has ≥ 1 of the following indications** for chemotherapy:
Has ≥ 1 of the following disease-related symptoms:
PATIENT CHARACTERISTICS:
Total bilirubin ≤ 3.0 times upper limit of normal (ULN) (unless due to Gilbert's disease)
None of the following cardiovascular conditions:
Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Principal Investigator: | Tait D. Shanafelt, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Research Consortium ( Regulatory Affairs Associate ) |
Study ID Numbers: | CDR0000630491, MCCRC-RC0783, MCCRC-08-002080 |
Study First Received: | December 31, 2008 |
Last Updated: | August 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00816595 History of Changes |
Health Authority: | Unspecified |
B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma |
Pentostatin Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Cyclophosphamide Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents Leukemia |
Lymphatic Diseases Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Antineoplastic Agents, Alkylating Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Alkylating Agents Lymphoma |
Leukemia, Lymphoid Pentostatin Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Bevacizumab Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Lymphoma Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Leukemia, B-Cell |