Trial Aimed at Reducing Complications After Half-Matched BMT for Thalassemia
- Conditions
- Health Condition 1: D561- Beta thalassemiaHealth Condition 2: D570- Hb-SS disease with crisis
- Registration Number
- CTRI/2019/04/018379
- Lead Sponsor
- Manashi Chakrabarti Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)First Transplantation
2)Diagnosis of Hemoglobinopathy
3)No major organ dysfunction
1)Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms) within 1 month prior to conditioning. Patients with febrile illness or suspected minor infection should await clinical resolution prior to starting conditioning.
2)Patients seropositive for the human immunodeficiency virus (HIV)
3)Patient with active Hepatitis B or C determined by serology and/or NAAT not on treatment
4)Active hepatitis, bridging fibrosis or cirrhosis on liver biopsy (biopsy required for patients on chronic transfusion therapy for > 1 year and evidence of iron overload with ferritin >1000 ng/mL)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Engraftment by Day 30. <br/ ><br> <br/ ><br> <br/ ><br>2)Incidence of grade IIâ??IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>3)Incidence of Post-Transplantation Hemophagocytic Syndrome <br/ ><br>Timepoint: 3 months <br/ ><br>6 months <br/ ><br>one year
- Secondary Outcome Measures
Name Time Method ÂIncidence and severity of chronic GVHD at 1 year and 2 years <br/ ><br>ÂIncidence of TRM at all visits throughout the study <br/ ><br>ÂIncidence and severity of acute infusional toxicities <br/ ><br>ÂGraft failure from Day 0 to Day 28 <br/ ><br>Timepoint: 3 months <br/ ><br>6 months <br/ ><br>one year <br/ ><br>two years