De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis

Running, not enrolling · Phase 2

Conditions studied: Graft-versus-host Disease

In brief

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.

Key facts

Study ID

NCT05622318

Run by

Medical College of Wisconsin

People needed

56

Starts

2023-08-29

Expected to finish

2026-09-01

Last updated by the study team

2026-03-12

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of hematologic malignancy.
• Must be in remission:
• Acute Leukemia, chronic leukemia, or myelodysplasia/myeloproliferative neoplasm (excluding primary myelofibrosis): No circulating blasts and <5% blasts in the bone marrow.
• Hodgkin and non-Hodgkin lymphomas: Chemo-sensitive disease at time of transplant
• 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.

You may not qualify if…

• Prior allogeneic HCT or Chimeric antigen receptor (CAR) -T cell therapy.
• Patients with liver dysfunction evidenced by bilirubin ≥2x upper limit normal (ULN), except for a history of Gilbert syndrome.
• Patients with renal impairment defined by creatinine<2mg/dL.
• 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.
• Pregnant or lactating subjects.

Where it is running

• Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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