Stem Cell Transplantation for Hematological Malignancies
Tracking Information | |||||
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First Received Date ICMJE | September 12, 2005 | ||||
Last Updated Date | May 30, 2012 | ||||
Start Date ICMJE | June 2000 | ||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To determine the probability of long-term disease-free survival (DFS) in patients treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
To determine the probability of long-term disease-free survival (DFS) in patients treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. | ||||
Change History | Complete list of historical versions of study NCT00176839 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Stem Cell Transplantation for Hematological Malignancies | ||||
Official Title ICMJE | Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies | ||||
Brief Summary | This protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well tolerated and will cure the patient. |
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Detailed Description | Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. Prior to transplantation, they will receive BUSULFAN via the central venous line, four times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's cancer. As well, these drugs will destroy their immune system to help ensure the new stem cells take and grow after transplantation. On the day of transplantation, umbilical cord blood from the donor will be transfused via venous line. These new cells will replace the subject's bone marrow. After transplantation, the subjects will receive Cyclosporin A and either MMF or MTX Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will be discharged from the hospital when medically ready. They will be expected to return for follow-up to the blood and marrow transplant clinic at specific dates as determined by physicians. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | Experimental: Treatment Arm
Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 20 | ||||
Estimated Completion Date | December 2015 | ||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | up to 35 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00176839 | ||||
Other Study ID Numbers ICMJE | 2000LS040, MT2000-12, 0005M52481 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Masonic Cancer Center, University of Minnesota | ||||
Study Sponsor ICMJE | Masonic Cancer Center, University of Minnesota | ||||
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Investigators ICMJE |
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Information Provided By | Masonic Cancer Center, University of Minnesota | ||||
Verification Date | May 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |