Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITING
Rockville Centre
Contact Information
Primary
Doris Ponce, MD
ponced@mskcc.org
646-608-3739
Backup
Miguel-Angel Perales, MD
peralesm@MSKCC.ORG
646-608-4044
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2029-05-21
Participants
Target number of participants: 46
Treatments
Experimental: Participants with hematologic malignancy in morphologic remission
Participants will be diagnosed with a hematologic malignancy in morphologic remission
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov