eflunomide for musculoskeletal GVHD after allogeneic stem cell transplant
Phase 2
- Conditions
- Health Condition 1: M95-M95- Other disorders of the musculoskeletal system and connective tissue
- Registration Number
- CTRI/2021/04/033214
- Lead Sponsor
- Dr Sachin Punatar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method