eflunomide to prevent Cytomegalovirus infection in Bone marrow transplantatio
Phase 2
- Conditions
- Health Condition 1: null- 1. Patients undergoing Haplo-identical stem cell transplantation (HHSCT)2. Patients undergoing matched unrelated donor transplantation (MUD HSCT)
- Registration Number
- CTRI/2017/06/008872
- Lead Sponsor
- Institutional support Academic study Christian Medicaol College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Patients undergoing Haplo-identical stem cell transplantation (HHSCT)
2. Patients undergoing matched unrelated donor transplantation (MUD HSCT)
3. Patients willing to sign informed consent
4. Patients > 2 years of age [willing to swallow oral tablets]
5. Patient should be CMV IgG + prior to HSCT.
6. Patients with stable engraftment [ANC >500/mm3 on 2 occasions 1 day apart]
Exclusion Criteria
1.Patients undergoing matched sibling donor transplantation
2.Patients who are CMV IgG negative prior to HSCT
3.Patients who are unable to swallow tablets
4.Patients will liver function tests > 5 ULN [SGPT >200, SGOT >200, Total Billirubin > 2 mg%] post engraftment
5.Patients who have already reactivated CMV prior to initiation of leflunomide.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method