Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia
NCT ID: NCT00002838
Last Updated: 2012-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
13 participants
INTERVENTIONAL
1995-12-31
2002-07-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.
Detailed Description
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OUTLINE: This is a nonrandomized, dose-seeking study. Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest. Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days, with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined. Three days after intensive chemotherapy, allogeneic stem cells are infused. Responding patients who do not experience worse than grade 1 acute graft-vs.-host disease receive additional stem cell infusions after 60 and 120 days. Patients are followed monthly for 4 months, at 6 and 12 months, then yearly for 5 years.
PROJECTED ACCRUAL: Up to 25 patients will be entered.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination Chemotherapy + PSCT
PSCT = Peripheral Stem Cell Transplantation
Filgrastim (G-CSF)
Cyclophosphamide
Fludarabine Phosphate
Peripheral Blood Stem Cell Transplantation
Interventions
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Filgrastim (G-CSF)
Cyclophosphamide
Fludarabine Phosphate
Peripheral Blood Stem Cell Transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1 Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease Other: No active uncontrolled infection
PRIOR CONCURRENT THERAPY: See Disease Characteristics
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Issa Khouri, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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MDA-DM-95194
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-V96-1018
Identifier Type: -
Identifier Source: secondary_id
CDR0000065053
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM95-194
Identifier Type: -
Identifier Source: org_study_id