Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
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ClinicalTrials.gov Identifier: NCT00134004 |
Recruitment Status :
Completed
First Posted : August 24, 2005
Results First Posted : August 24, 2015
Last Update Posted : October 6, 2015
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Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Interventions |
Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
Enrollment | 210 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Mini-haplo BMT |
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Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. |
Period Title: Overall Study | |
Started | 210 |
Completed | 210 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Mini-haplo BMT | |
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Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. | |
Overall Number of Baseline Participants | 210 | |
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[Not Specified]
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 210 participants | |
52
(1 to 73)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 210 participants | |
Female |
61 29.0%
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Male |
149 71.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 210 participants |
210 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Ephraim Fuchs |
Organization: | Johns Hopkins University |
Phone: | 410-419-6479 |
EMail: | fuchsep@jhmi.edu |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT00134004 |
Other Study ID Numbers: |
J0457 CDR0000440990 P01CA015396 ( U.S. NIH Grant/Contract ) P30CA006973 ( U.S. NIH Grant/Contract ) JHOC-J0457 ( Other Identifier: Johns Hopkins SKCCC ) JHOC-04072704 |
First Submitted: | August 22, 2005 |
First Posted: | August 24, 2005 |
Results First Submitted: | June 26, 2015 |
Results First Posted: | August 24, 2015 |
Last Update Posted: | October 6, 2015 |