Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
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ClinicalTrials.gov Identifier: NCT00134017 |
Recruitment Status :
Completed
First Posted : August 24, 2005
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
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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: Busulfan Drug: Cyclophosphamide |
Enrollment | 142 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Bone Marrow Transplant |
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Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis. |
Period Title: Overall Study | |
Started | 142 |
Completed | 142 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Bone Marrow Transplant | |
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Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis. | |
Overall Number of Baseline Participants | 142 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 142 participants | |
<=18 years |
16 11.3%
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Between 18 and 65 years |
123 86.6%
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>=65 years |
3 2.1%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 142 participants | |
47
(21 to 66)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 142 participants | |
Female |
66 46.5%
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Male |
76 53.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Leo Luznik, MD |
Organization: | Johns Hopkins University |
Phone: | 4105027732 |
EMail: | luznile@jhmi.edu |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT00134017 |
Other Study ID Numbers: |
J0373 P01CA015396 ( U.S. NIH Grant/Contract ) P30CA006973 ( U.S. NIH Grant/Contract ) NA_00034100 ( Other Identifier: JHMIRB ) |
First Submitted: | August 22, 2005 |
First Posted: | August 24, 2005 |
Results First Submitted: | July 31, 2018 |
Results First Posted: | August 31, 2018 |
Last Update Posted: | August 31, 2018 |