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Clinical Trials/CTRI/2021/04/033214
CTRI/2021/04/033214
Recruiting
Phase 2

Pilot study of leflunomide as first line therapy for musculoskeletal GVHD

Dr Sachin Punatar0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr Sachin Punatar
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
Dr Sachin Punatar

Eligibility Criteria

Inclusion Criteria

  • •1\. Willing to give written informed consent
  • •2\. Patients diagnosed with musculoskeletal mGvHD based on 2014 NIH consensus criteria (with diagnosis confirmed by biopsy only if clinically required).
  • •3\. Willing and able to comply with all study requirements, including treatment, and periodic assessments.

Exclusion Criteria

  • •1\. Patients with known hypersensitivity to leflunomide especially previous Steven Johnson syndrome, toxic epidermal necrolysis after leflunomide.
  • •2\. Pregnant females
  • •3\. Patients with musculoskeletal manifestations explained by other potential causes (drugs, trauma, etc).
  • •4\. Patients with calculated GFR \<30ml/min at the time of screening.

Outcomes

Primary Outcomes

Not specified

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