A Novel TBI Free Conditioning Protocol for Haploidentical Transplant in Acquired Aplastic Anemia: (FluCAB-Prime)
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|ClinicalTrials.gov Identifier: NCT03955601|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aplastic Anemia Idiopathic||Drug: Haploidentical HSCT using TBI free regimen, ''ATG'' with ''Post transplant cyclophosphamide''||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel TBI Free Conditioning Protocol for Haploidentical Hematopoeitic Stem Cell Transplant in Acquired Aplastic Anemia|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: TBI free Haploidentical HSCT
Recipients will receive a reduced intensity conditioning regimen of ''Fludarabine'' 30 mg/m2 IV daily from day -7 to -3, ''Cyclophosphamide'' 14.5-30 mg/kg IV daily on day -6 and -5 , ''rabbit Antithymocyte globulin'' 5 mg /kg/day from day -6 to day-3; ''Busulphan'' IV 3.2 mg per kg/day in 02 divided doses on day -3 and day-2, ''Granulocyte Colony Stimulating factor primed Bone marrow harvest'' and/OR ''PBSC'' graft on day 0 and day +1 respectively and Graft versus host disease prophylaxis with ''post-transplant cyclophosphamide'' administered at a dose of 50mg/kg/day given daily on days +3 and +5 post-transplant and ''cyclosporine'' from day +5, ''mycophenolate mofetil'' from day+5 to day+35.
Drug: Haploidentical HSCT using TBI free regimen, ''ATG'' with ''Post transplant cyclophosphamide''
''Busulphan'' will be used in place of ''TBI'' in equivalent myelotoxic dose to facilitate engraftment , ''ATG'' will be used to reduce GVHD and facilitate engraftment while ''combine PBSC'' and/OR ''Bone marrow harvest'' will be used
Other Name: ''Combined BMH'' and ''PBSC harvest''
- Number of Participants with overall survival [ Time Frame: from the date of transplant to 1 year post transplant ]overall survival is defined as the time interval from date of transplant to death or to last follow-up, whichever occurs first.
- Number of Participants with Disease free survival [ Time Frame: from the date of transplant to 1 year post transplant ]from time of transplant to death or last follow up
- Time of Neutrophil engraftment [ Time Frame: from the date of transplant to 10 to day 28 post transplant ]first of 3 consecutive days with Absolute neutrophil count> 0.5
- Frequency of Graft versus host disease [ Time Frame: from the date of transplant to acute upto 100 day post transplant, chronic >100 days post transplant ]as per clinical and histopathological diagnosis
- Rate of Complications [ Time Frame: from the date of transplant to 1 year from day of transplantation ]both infectious and non infectious
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): NCT03955601
|Contact: Xanab firstname.lastname@example.org|
|Rawalpindi, Punjab, Pakistan, 46000|
|Contact: Tariq Mehmood Satti, FCPS, MCPS +92-51-9270076 ext 201 email@example.com|
|Sub-Investigator: Xanab Akram|
|Study Chair:||Tariq Mehmood Satti, FCPS||NIBMT|