Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer
NCT ID: NCT00546377
Last Updated: 2016-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2005-07-31
2014-05-31
Brief Summary
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PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell cancer.
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Detailed Description
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* Phase I: Patients receive pentostatin IV, cyclophosphamide IV, and mitoxantrone hydrochloride IV on day 1. Patients also receive rituximab IV on day 1 beginning in course 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Phase II: Patients receive pentostatin, cyclophosphamide, rituximab, and mitoxantrone hydrochloride (at the maximum tolerated dose determined in phase I) as in phase I.
All patients receive either pegfilgrastim subcutaneously (SC) on days 1-4 following each course or filgrastim or sargramostim SC beginning 2 days after each course until blood counts recover.
Patients undergo blood collection and bone marrow biopsy periodically for assessment of therapy response by biomarker and laboratory studies. Samples are analyzed for molecular genetics for IgH arrangement by PCR and for response by immunoelectrophoresis. Some samples are analyzed for response by flow cytometry or fluorescence in situ hybridization (FISH).
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 63 patients (18 patients for phase I and 45 patients for phase II) will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mitoxantrone
filgrastim
pegfilgrastim
rituximab
sargramostim
cyclophosphamide
mitoxantrone hydrochloride
pentostatin
fluorescence in situ hybridization
gene rearrangement analysis
polymerase chain reaction
protein expression analysis
flow cytometry
biopsy
Interventions
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filgrastim
pegfilgrastim
rituximab
sargramostim
cyclophosphamide
mitoxantrone hydrochloride
pentostatin
fluorescence in situ hybridization
gene rearrangement analysis
polymerase chain reaction
protein expression analysis
flow cytometry
biopsy
Eligibility Criteria
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Inclusion Criteria
* No significant active infections
* No ongoing hepatitis B infection, specifically hepatitis B antigen or surface antigen positivity
* Hepatitis B antibody-positive patients are eligible
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* The following concurrent medications are allowed:
* Intravenous immunoglobulin (IVIG)
* Erythropoietin, darbepoetin, filgrastim, or sargramostim
* Cyclosporine (only for patients with cellular immune cytopenias \[i.e., pure red cell aplasia\]), with required consultation of the principle investigator or designee
* Concurrent prednisone allowed provided it is used as brief courses (≤ 7 days) for inflammatory conditions unrelated to CLL
* No concurrent chemotherapy or radiotherapy
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Renier Brentjens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Andrew D. Zelenetz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-05077
Identifier Type: -
Identifier Source: secondary_id
05-077
Identifier Type: -
Identifier Source: org_study_id
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