Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
NCT ID: NCT00002844
Last Updated: 2018-10-25
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
PHASE2
49 participants
INTERVENTIONAL
1991-03-05
2002-06-05
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with chronic lymphocytic leukemia.
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Detailed Description
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OUTLINE: Patients receive daily intravenous infusions of cyclophosphamide for two days, followed by total body irradiation in four daily exposures. After completion of the total body irradiation, allogeneic or autologous bone marrow is infused intravenously.
PROJECTED ACCRUAL: 50 patients are expected to be accrued.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cyclophosphamide + TBI + BMT
TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)
Cyclophosphamide
Daily intravenous infusions of cyclophosphamide for two days,
Allogeneic Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Autologous Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Total Body Irradiation (TBI)
Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
Interventions
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Cyclophosphamide
Daily intravenous infusions of cyclophosphamide for two days,
Allogeneic Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Autologous Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
Total Body Irradiation (TBI)
Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: No extensive prior radiotherapy which would prevent administration of total body radiation Patients may also participate in study MDA-DM-92082 for retroviral gene marking of the autologous marrow and blood cells
16 Years
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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Richard E. Champlin, 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-90106
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G96-1034
Identifier Type: -
Identifier Source: secondary_id
CDR0000065081
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM90-106
Identifier Type: -
Identifier Source: org_study_id
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