The use of a novel biological drug to prevent and treat chronic graft rejection in patients who have undergone a bone marrow transplant
Phase 3
- Conditions
- Health Condition 1: D899- Disorder involving the immune mechanism, unspecified
- Registration Number
- CTRI/2020/03/024056
- Lead Sponsor
- arayana Hrudayalaya Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or nonmyeloablative conditioning regimens
Having clinical diagnosis of chronic GVHD extensively involving skin or Musculoskeletal system - NIH severity score 2 or above
Exclusion Criteria
-Patients who do not give consent to receive the treatment.
-Patients who relapse after haematopoietic stem cell transplantation or have
undergone 2nd transplantation for relapse.
-Patients with high-risk malignancy requiring early taper of
immunosuppressants.
-Evidence of post-transplant lymphoproliferative disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in GVHD symptoms and the incidence of adverse events.Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method ilTimepoint: 1 year