CTRI/2017/06/008872
Not yet recruiting
Phase 2
A Pilot study of Leflunomide to prevent Cytomegalovirus (CMV) reactivation in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) - Not applicable
Institutional support Academic study Christian Medicaol College Vellore0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- 1. Patients undergoing Haplo-identical stem cell transplantation (HHSCT)2. Patients undergoing matched unrelated donor transplantation (MUD HSCT)
- Sponsor
- Institutional support Academic study Christian Medicaol College Vellore
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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