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Not yet recruiting NCT07734012

Mycophenolate After Stem Cell Transplant for Systemic Sclerosis

Phase II Interventional Systemic Sclerosis (SSc)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mycophenolate Mofetil 1000 mg twice daily.
Who it may be relevant to
Registry conditions: Systemic Sclerosis (SSc). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immunomodulatory Maintenance Therapy Post-Autologous Hematopoietic Stem Cell Transplantation for Prevention of Systemic Sclerosis Relapse: A Pilot Randomized Trial

Overview

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.

Detailed description

This study is performed determine the feasibility of a larger pragmatic RCT to evaluate the effectiveness of post- Autologous Hemopoietic Stem Cell Transplant (AHSCT) maintenance therapy with mycophenolate mofetil (MMF) in the prevention of Systemic sclerosis (SSc) relapse.

The study will include 6 participants who will be randomized at 1:1 ratio to treatment (MMF) or control arm (no treatment) for 6 months.

The participants will have 6 visits in total : An initial clinic visit will occur prior to stem cell collection. Post-AHSCT, in-person follow-up visits are scheduled on days 30, 90, 180, 270, and 300, with windows of +/- 1 week for days 30 and 90 and +/- 2 weeks for days 180, 270 and 300.

These visits will be coordinated at an established multidisciplinary (Rheumatology + Cell Therapy) clinic that are part of the patient's clinical care. At each visit, the participants will be asked to complete health questionnaires and laboratory tests will be performed as part of the standard of care of AHSCT recipients.

Interventions

  • Drug Mycophenolate Mofetil 1000 mg twice daily
    MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT and continued for 6 months.

Primary outcome measures

  • Feasibility: [Time frame: 18 months]
  • Efficacy : [Time frame: At day 0,90,180 and 270]
  • Safety : AEs/SAEs [Time frame: Day 90 (treatment start) , Day 180, day 270]
  • Efficacy: [Time frame: At day 0,90,180 and 270]
Secondary outcome measures (8)
  • Feasibility: Consent rate: [Time frame: Both prior to AHSCT (clinic visit #1) and at day 90 (clinic visit #3) prior to randomization.]
  • Feasibility: Retention rate: Proportion of participants retained [Time frame: Day 270 (clinic visit #5)]
  • Feasibility: Study completion rate: [Time frame: Day 270]
  • Feasibility: Adherence rate: [Time frame: Day 180 and Day 270]
  • Clinical outcomes: [Time frame: day 0, 90, 180 and 270]
  • Auto-antibody testing (clinical) [Time frame: Prior to AHSCT and Day 180 (visit# 4)]
  • Clinical outcome: [Time frame: day 0,90,180 and 270]
  • Clinical outcome: [Time frame: Day 0,90,180 and 270]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • The Ottawa Hospital — Ottawa

Identifiers

NCT: NCT07734012 · 20260406-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗