Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia
NCT ID: NCT00003659
Last Updated: 2017-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
1998-09-30
2009-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia.
Detailed Description
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* Determine the response rate in patients with chronic lymphocytic leukemia treated with sequential fludarabine, high dose cyclophosphamide, and rituximab.
* Survival up to 5 years
* Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal residual disease in these patients.
OUTLINE: This is an open label study.
Patients receive fludarabine IV once daily for 5 days. Treatment is repeated every 4 weeks for 3 or 6 courses.
Three weeks later, cyclophosphamide is administered intravenously every 2-3 weeks for 3 courses. Filgrastim (G-CSF) is administered on days 2-10. Beginning 4 weeks after the last dose of cyclophosphamide, patients receive rituximab by intravenous infusion once weekly for 4 weeks.
Patient are followed every 3 months until death.
PROJECTED ACCRUAL: This study will accrue 30 patients within 3 years.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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intermediate or high risk chronic lymphocytic leukemia
This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
filgrastim
Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.
rituximab
Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.
cyclophosphamide
Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.
fludarabine phosphate
Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.
Interventions
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filgrastim
Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.
rituximab
Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.
cyclophosphamide
Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.
fludarabine phosphate
Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Patients must be previously untreated (with cytoreductive agents) for their CLL.
* The patient must have an absolute lymphocytosis in the blood of at least 5,000 lymphocytes/μl, or bone marrow lymphocytosis greater than or equal to 30% of all nucleated cells. These lymphocytes must have an appropriate immunophenotype for CLL including expression of CD5 and CD20.
* Karnofsky performance status equal to or greater than 60% (see Appendix B).
* Eligible patients should have a reasonable life-expectancy greater than four weeks.
* Age ≥ 18 years and ≤ 75 years.
* Total bilirubin ≤ 2.0 mg per deciliter. Total creatinine ≤ 2.0 mg/ dl.
* Platelet count ≥ 50,000/ ul.
* Signed informed consent, which indicates the investigational nature of this, is required.
* No patient may be entered onto the study without consultation with the principal investigator.
Exclusion Criteria
* Patients with significant autoimmune hemolytic anemia or autoimmune thrombocytopenia shall not be eligible for treatment on this protocol as there is some evidence that fludarabine can worsen these conditions.
* Patients with active infections requiring systemic antibiotics.
* Prior cytotoxic treatment of their CLL.
* Pregnant or lactating women. Women and men of childbearing age should use effective contraception.
* Patients with a serious cardiac condition.
* Concomitant chemotherapy or radiotherapy while on protocol.
* Concomitant prednisone therapy will not be permitted as the combination of fludarabine and prednisone is known to increase the risk of opportunistic infections. Patients may receive intravenous immunoglobulin (IVIG) and other supportive care measures as clinically appropriate while on protocol.
18 Years
75 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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Mark Adam Weiss, MD
Role: STUDY_CHAIR
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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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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MSKCC-98080
Identifier Type: -
Identifier Source: secondary_id
NCI-G98-1483
Identifier Type: -
Identifier Source: secondary_id
98-080
Identifier Type: -
Identifier Source: org_study_id