Mycophenolate After Stem Cell Transplant for Systemic Sclerosis
ConditionSystemic Sclerosis (SSc)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
A pilot single center randomized trial to test whether a full-scale RCT evaluating the role of post-AHSCT maintenance immunosuppression with MMF in preventing disease relapse is feasible .
We are studying whether a brief course of treatment with MMF after AHSCT will serve to prevent disease relapse.
Eligibility criteria
Qualifiers
Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc.
Disqualifiers
Exclusion criteria are focused on patient safety, namely inability to receive treatment with
Renal insufficiency (eGFR <25 mL/minute/1.73m2) or
Neutropenia (ANC <1.0 x 103/mcL) or
Thrombocytopenia (platelet count <50 000/mcL)
Trial design
Treatments tested in this trial
- Mycophenolate Mofetil 1000 mg twice daily
Treatment groups
6 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ottawa Hospital Research Institute
Lead sponsor
The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.
Collaborator
Source ClinicalTrials.gov