BridgeMD
Compares treatment options for Graft Versus Host Disease
Official title A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
ClinicalTrials.gov ID: NCT07006506
What this study is testing
What is Belumosudil?
Belumosudil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for graft versus host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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 (within 3 weeks before start of belumosudil treatment)
You likely can't join if
- 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...
- 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...
- Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within...
See the full eligibility 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 (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...
- 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...
- 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 people 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...
- For male people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.