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Clinical Trials/CTRI/2017/06/008872
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Institutional support Academic study Christian Medicaol College Vellore

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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