Health Condition 1: M95-M95- Other disorders of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Leflunomide: Leflunomide will be given at standard dose (100 mg OD x 3 days followed by 20 mg OD) in adults and weight based dose in children
Control Intervention1: Nil: Not applicable
Sponsors
Dr Sachin Punatar
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall objective response rateTimepoint: At any time following start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of responseTimepoint: Time from first response to relapse or progression of musculoskeletal GVHD;Relapse rateTimepoint: Proportion of patients relapsing after attaining a response;Time to best responseTimepoint: Time from start of leflunomide to the best response;Time to responseTimepoint: Time from start of leflunomide to attainment of any response | — |
Countries
India
Contacts
Public ContactSachin Punatar
Tata Memorial Centre
Outcome results
None listed