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Clinical Trials/CTRI/2024/05/067949
CTRI/2024/05/067949
Not yet recruiting
Phase 2

se of Leflunomide as Primary Prophylaxis against Cytomegalovirus (CMV) Reactivation in Haploidentical Haematopoietic Stem Cell Transplant (HIT) Single arm Phase 2 Clinical Trial - NI

Tata Memorial Hospital0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Tata Memorial Hospital
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Males or females undergoing Haplo\-identical haematopoetic stem cell transplant.
  • •\-Undetectable CMV from plasma sample in preceding 7 days
  • •\-Patient who has WBC engraftment ANC More than 500 per cu mm for 3 or more consecutive
  • •\-Within 7 days of WBC engraftment
  • •\-Adequate liver functions ALT or AST less than 5 times upper limit of normal and
  • •Bilirubin less than 3 times upper limit of normal at time of starting leflunomide
  • •\-Understands the study procedures, alternative treatment available and risks involved
  • •with the study and voluntarily agree to participate by giving written informed

Exclusion Criteria

  • •\-Known hypersensitivity to Leflunomide
  • •\-History of clinically significant CMV reactivation in past 1 year
  • •\-Patient is receiving or has received drug known to have anti CMV activity within in last
  • •7 days Ganciclovir, valganciclovir, foscarnet, letermovir, acyclovir at doses more than 3200
  • •mg PO per day or more than 25 mg/kg IV per day), valacyclovir (at doses More than 3000 mg PO per day
  • •\-Inadequate renal function creatinine clearance less than 30 ml per min
  • •\-Chronic active hepatitis B (HBsAg\+ or any HBV DNA\+), hepatitis C, or/\& HIV
  • •\-Any psychiatric condition that might limit the ability of the patient to comply with the

Outcomes

Primary Outcomes

Not specified

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