Phase 3: testing Belumosudil for Chronic Graft Versus Host Disease
You would be randomly assigned 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation.
Official registry: https://clinicaltrials.gov/study/NCT07771439 · Sanofi · enrollment listed as 356
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Belumosudil, or Best available therapy (BAT). The registry lists allocation as randomized. You would be randomly assigned 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2).
They plan to enroll about 356 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Parallel Group, Phase 3, Randomized, Open-label, 2-arm Study to Demonstrate the Superiority of Belumosudil Versus Best Available Therapy (BAT) in Participants at Least 12 Years of Age With Chronic Graft Versus Host Disease (cGVHD) Refractory to or Recurrent After 2 to 5 Prior Lines of Systemic Therapy
Interventions: Belumosudil, Best available therapy (BAT)
Primary outcome (registry wording): Overall response rate
Who it is for (from inclusion criteria)
- Ages 12 Years to any
- Participants who have undergone allo-HCT
- Participants with active moderate to severe cGVHD at the time of enrollment, defined using the NIH Consensus diagnosis and staging criteria for which the physician believes a new line of systemic therapy is required
- Participant receiving systemic CNI and/or CS must be on a stable dose/regimen (prednisone equivalent \<1 mg/kg/day for CS) for at least 2 weeks prior to randomization
- cGVHD is refractory to, or has recurred following, at least 2 prior lines of systemic treatment. Participants must have received a minimum of 2 and a maximum of 5 prior systemic therapies for cGVHD
- Participant must have received ruxolitinib for the treatment of cGVHD unless the Investigator believes treatment with ruxolitinib for cGVHD was not suitable for the participant
- Participants and/or their LAR must accept to be treated with 1 of the following BAT options as recommended to them by the Investigator on Cycle 1 Day 1:
- mTOR inhibitors (sirolimus, everolimus)
Who the registry excludes
- Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease or post-transplant lymphoproliferative disease after most recent allo-HCT
- Participants who meet any of the following criteria regarding systemic cGVHD treatments:
- Participants who newly initiated any systemic cGVHD treatment within 14 days prior to the date of randomization
- Participants receiving systemic ruxolitinib treatment who are unable to meet the following requirements:
- Ruxolitinib must be tapered and discontinued within 14 days following the first dose of belumosudil or BAT (allowing for a maximum overlap period of up to 14 days with belumosudil or BAT treatment)
- No dose increases of ruxolitinib are permitted from 14 days prior to the date of randomization until permanent discontinuation of ruxolitinib (dose reductions and discontinuations are permitted during this period)
- Participants receiving other systemic cGVHD treatment (apart from CS and CNI) including investigational treatments who have not completed a washout period of at least 14 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil or BAT treatment
Public study contact (from the registry)
Trial Transparency email recommended (Toll free for US & Canada)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- Investigational Site Number : 5280001 — Amsterdam, Netherlands (recruiting)
- Investigational Site Number : 7240008 — Madrid, Madrid, Comunidad de, Spain (recruiting)
- Investigational Site Number : 7240009 — Madrid, Spain (recruiting)
FAQ about this NCT record
Is NCT07771439 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07771439?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07771439?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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