Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
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|ClinicalTrials.gov Identifier: NCT01244906|
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : March 17, 2015
Last Update Posted : May 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Neoplasms||Procedure: Allogeneic Hematopoietic Stem Cell Transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Post-Transplant Cyclophosphamide and Sirolimus for Graft-versus-host Disease (GVHD) Prophylaxis Following Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation|
|Study Start Date :||December 2010|
|Primary Completion Date :||April 2014|
|Study Completion Date :||December 2014|
Experimental: Reduced Intensity Allogeneic Stem Cell Transplantation
All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
- Incidence of GVHD [ Time Frame: 1 year ]To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.
- Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment [ Time Frame: Approximately Day 30 ]To estimate the incidence of neutrophil and platelet engraftment
- Number of Participants With Non-Relapse Mortality [ Time Frame: 1 year ]
- Number of Patients With Disease Free Survival at 2 Years [ Time Frame: 2 years ]
- Number of Patients to Achieve Full Donor Chimerism [ Time Frame: 1 year ]Characterize rate of achievement of full donor chimerism
- Number of Patients With Overall Survival at 2 Years. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244906
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||Scott R Solomon, MD||Blood and Marrow Transplant Group of Georgia|