Mycophenolate After Stem Cell Transplant for Systemic Sclerosis | NCT07734012

NCT07734012

Overview

NCT ID: NCT07734012
Lead Sponsor: Ottawa Hospital Research InstituteOTHER
Official Title: Immunomodulatory Maintenance Therapy Post-Autologous Hematopoietic Stem Cell Transplantation for Prevention of Systemic Sclerosis Relapse: A Pilot Randomized Trial
Brief Summary: 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.
Conditions: Systemic Sclerosis (SSc)
Interventions: Mycophenolate Mofetil 1000 mg twice daily

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc.

Exclusion Criteria:

Exclusion criteria are focused on patient safety, namely inability to receive treatment with

MMF due to contraindications as determine at time of randomization (day 90 / clinic visit #3) including:

Renal insufficiency (eGFR <25 mL/minute/1.73m2) or

Neutropenia (ANC <1.0 x 103/mcL) or

Thrombocytopenia (platelet count <50 000/mcL)

Previously documented intolerance.

Pregnant or breastfeeding - Women of childbearing potential who are not willing to use a highly effective method of contraception for the duration of study participation will be excluded

Central Contacts: Clinical Research AssistantContact
nasaidi@ohri.ca613 738 8400 ext. 81630