NCT07734012Not yet recruitingPhase 2
Mycophenolate After Stem Cell Transplant for Systemic Sclerosis
Immunomodulatory Maintenance Therapy Post-Autologous Hematopoietic Stem Cell Transplantation for Prevention of Systemic Sclerosis Relapse: A Pilot Randomized Trial
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07734012
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 6
- From Dec 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Previously documented intolerance.
Lab values
- Renal insufficiency (eGFR \<25 mL/minute/1.73m2) or
- Neutropenia (ANC \<1.0 x 103/mcL) or
- Thrombocytopenia (platelet count \<50 000/mcL)
Other
- 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
Who the study is looking for
- Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.