Belumosudil to prevent graft-versus-host disease after a stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial adds belumosudil to usual GVHD prophylaxis in adults who received a peripheral blood allogeneic stem cell transplant for a hematologic malignancy in morphologic remission. Eligible participants are within 120 days post-transplant, have engrafted, and received CNI-based prophylaxis with abatacept or PTCY-containing regimens from matched or haploidentical donors. The study will monitor incidence of GVHD and safety outcomes while patients receive belumosudil alongside standard care. Investigators will compare outcomes to expected rates with current prophylaxis approaches to see if belumosudil reduces early post-transplant GVHD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients ≥ 18 years-old at time of consent.
* Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).
* Recipients of 7-8/8 related or unrelated HLA-matched or related haploidentical donor.
* Peripheral blood stem cell graft
* Allo-HCT day \<120 at time of consent

Post-HCT inclusion criteria (within 3 weeks before start of belumosudil treatment)

* Patient has received an allo-HCT transplant and is in morphologic remission (blasts \<5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed.
* Patient has achieved engraftment. Engraftment is defined as ANC≥500/μL and platelets ≥ 20000/μL on 3 consecutive measurements (each occurring at least 1 day apart). The patient must not have had a platelet transfusion within 7 days before the first measurement.
* Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.
* Karnofsky score ≥ 70%.
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)
* Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).
* Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2
* Female subjects of childbearing potential (≤ 50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.

  ° Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes: \* Intrauterine device (IUD) plus one barrier method \* Stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method \* 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \* A vasectomized partner
* For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug.

Exclusion Criteria:

* Recipient of CD34+ selected or engineered stem cell graft.
* Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin).
* Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
* Pulmonary dysfunction with DLCO \<50% corrected for hemoglobin
* Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.

Post-HCT exclusion criteria

* Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment.
* Use of investigational agent within 14 days pre-HCT or anytime thereafter.
* Active acute or chronic GVHD requiring systemic therapy (topical or local therapies are allowed).
* Active treatment with corticosteroids at a dose of ≥ 0.25 mg/kg/day for non-GVHD indication.
* Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
* Female patient who is pregnant or breastfeeding.
* Prior therapy with belumosudil.
* Known allergy or sensitivity to belumosudil or any other ROCK2 inhibitor.

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• New York University (Data Collection Only)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Doris Ponce, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Doris Ponce, MD
• Email: ponced@mskcc.org
• Phone: 646-608-3739

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.