GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT02360111|
Recruitment Status : Terminated (Lack of accrual)
First Posted : February 10, 2015
Results First Posted : November 8, 2018
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma||Drug: Cyclophosphamide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: Post Transplant Cyclophosphamide
Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.
- # GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria) [ Time Frame: 2 years ]Chronic GVHD will be diagnosed and graded according to the (NIH criteria) treated with standard or experimental immunosuppressive therapy.
- Disease-free Survival [ Time Frame: 2 years ]DFS is defined as the minimum interval of time to relapse/recurrence, to death or to the last follow-up, from the time of transplant
- Overall Survival [ Time Frame: 2 years ]Overall survival is defined as time from transplant to death or last follow-up.
- # Renal Insufficiency Defined as a Calculated eGFR <60 ml/Min/1.73m2. Those With a eGFR < 30 ml/Min/1.73m2 Will be Considered Ineligible. [ Time Frame: 2 years ]Renal insufficiency is defined as a calculated eGFR <60 ml/min/1.73m2. Those with a eGFR < 30 ml/min/1.73m2 will be considered ineligible.
- The Occurrence of Life-threatening Opportunistic Infections [ Time Frame: 2 years ]will be evaluated according to the criteria established by BMT CTN , and will be correlated with the level of immune recovery.
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): NCT02360111
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ann Jakubowski, Ph.D., M.D.||Memorial Sloan Kettering Cancer Center|