To Check Safety and Efficacy Abatacept vs Low dose ATG in Stem cell transplant patients
Phase 3
- Conditions
- Health Condition 1: D728- Other specified disorders of whiteblood cells
- Registration Number
- CTRI/2023/11/060233
- Lead Sponsor
- o Sponsor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion Criteria: All Patients who undergo HSCT for hematological malignancies.
All patients and/or their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria
Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression.
Pregnancy (positive serum B-HCG) or breastfeeding.
Known hypersensitivity reactions to Abatacept/ATG
Method of randomization: simple (1:1)
Method of allocation concealment: none, since this is an open-labelled study
Expected date of first enrolment: 31st November 2023
Estimated duration of trial: 3 years
Sponsor: none (Investigator initialed trial)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of acute GVHD day +28, +60, +100, +180 and +365 <br/ ><br>Grade III-IV acute GVHD at day +28, +60, +100, +180 and +365 <br/ ><br>Incidence of steroid-refractory GVHD at day +28, +60, +100, +180 and +365 <br/ ><br>Incidence and severity of Chronic GVHD at day +100, +180 and +365 <br/ ><br>Timepoint: At Last follow up
- Secondary Outcome Measures
Name Time Method At the last follow-up <br/ ><br>GRFS <br/ ><br>Incidence of opportunistic infections, such as: cytomegalovirus (CMV) reactivation, reactivation of other viral infections (EBV, etc.), bacterial sepsis <br/ ><br>Relapse of hematologic malignancies <br/ ><br>Timepoint: Till Last follow up