Methods to reduce GVHD after bone marrow transplant for aplastic anemia
Phase 3
- Conditions
- Health Condition 1: D618- Other specified aplastic anemias and other bone marrow failure syndromes
- Registration Number
- CTRI/2019/06/019765
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. All patients with Aplastic Anemia above the age of 15years
2. Has a 6/6 or 9/10 HLA matched sibling or family donor
3. Willing to sign consent
Exclusion Criteria
1. Presence of active infection at the time of HSCT
2. Use of ATG during conditioning
3. Use of bone marrow as graft source
4. Diagnosis of Fanconi anemia or other inherited bone marrow failure
disorders
5. Use of any of the other conditioning regimens for AA
6. Liver abnormalities that precludes the use of methotrexate
7. Cardiac abnormalities that precludes the use of cyclophosphamide
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the incidence of chronic GVHD at 24 months in patients receiving prophylaxis with PTCy compared to CSA/MTXTimepoint: 24 months
- Secondary Outcome Measures
Name Time Method 1. To compare the incidence of regimen related toxicity and Day 100 mortality with early versus late cyclophosphamide administration during conditioning. <br/ ><br>2. To compare infectious complications with the use of PTCy versus CM as GVHD prophylaxis after SCT <br/ ><br>3. To compare immune reconstitution following the use of PTCy versus CM as GVHD prophylaxis <br/ ><br>4. To compare Overall and GVHD free survival in patients receiving either PTCy or CM as GVHD prophylaxisTimepoint: 100 days