De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophyl… (NCT05622318) | Clinical Trial Compass
Active — Not RecruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
United States56 participantsStarted 2023-08-29
Plain-language summary
This is an open-label phase 2 study designed to explore the efficacy and safety of low-dose PTCy-ruxolitinib GVHD prophylaxis in older adults undergoing allogeneic HCT with a matched sibling or unrelated donor with a peripheral blood stem cell graft.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. History of hematologic malignancy.
✓. Must be in remission:
✓. Patients must have a related or unrelated peripheral blood stem cell donor that is an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donors must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation.
✓. Planned reduced intensity conditioning therapy with fludarabine/melphalan, with total dose of melphalan of 100-140 mg/m\^2 IV or fludarabine/busulfan with total dose of busulfan of 6.4 mg/kg IV.
✓. Karnofsky Performance Scale of 60 or greater.
✓. Male participants must agree to abstinence or to use of barrier contraception during the entire study period.
✓. Female participants of childbearing potential will require a negative pregnancy test and should agree to practice two effective methods of contraception during the entire study period.
✓. Ability to understand a written informed consent document, and the willingness to sign it.
✕. Patients with cardiac dysfunction defined by a left ventricular ejection fraction ≤45%.
✕. Patients with pulmonary dysfunction defined by a forced expiratory volume in the first second (FEV1) or diffusing capacity for carbon monoxide (DLCO) (corrected for hemoglobin) ≤50% of predicted.
✕. Patients with a chronic or active infection requiring systemic treatment during and after transplant.
✕. Presence of other active malignant disease diagnosed within 12 months, except for adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less, or cervical intraepithelial neoplasia. Active malignancy is malignancy receiving treatment.