Study on Low Dose Cyclophosphamide, Tacrolimus, and Ruxolitinib for Preventing Graft-versus-Host Disease in Stem Cell Transplant Patients

Sponsor: Hannah Choe, MD

Sponsor score: 0

ClinicalTrials ID:NCT07249346

Provider View

This clinical trial is testing a new approach to prevent graft-versus-host disease (GVHD) in patients undergoing stem cell transplants. The study uses a combination of low dose cyclophosphamide, tacrolimus, and ruxolitinib after the transplant to see if it can help patients avoid severe GVHD.

Patient Parameters

Program Overview

The study aims to find out if using low doses of cyclophosphamide, along with tacrolimus and ruxolitinib, can prevent severe graft-versus-host disease (GVHD) in patients who have received a stem cell transplant. This approach is being tested in patients who have undergone a type of transplant called myeloablative allogeneic peripheral blood stem cell transplantation, which involves using high doses of chemotherapy to prepare the body for the transplant.

Description

The main goal of this study is to see if patients can survive without developing severe Grade 3-4 acute GVHD within 180 days after their stem cell transplant. The study will also look at other outcomes, such as the rates of different grades of acute and chronic GVHD, recovery of blood cells, relapse or progression of the disease, and overall survival. Patients will receive low doses of cyclophosphamide, tacrolimus, and ruxolitinib as part of their treatment to prevent GVHD.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Undergoing a stem cell transplant for conditions like acute leukemia or myelodysplastic syndromes.
  • Must have a suitable stem cell donor, either a sibling or an unrelated donor, who matches specific genetic criteria.
  • Must have good heart, kidney, lung, and liver function.
  • Must be in good overall health with a performance score of at least 70%.
  • Women of childbearing potential must use two forms of birth control or abstain from sex during and after the study.
  • Men must use effective birth control or abstain from sex during and after the study.
  • Must disclose any plans for post-transplant maintenance therapy.
  • Must provide written consent to participate in the study.

Exclusion Criteria

  • Previous stem cell transplant.
  • Active cancer in the central nervous system.
  • Certain types of secondary acute myeloid leukemia.
  • Uncontrolled infections or active tuberculosis.
  • HIV with detectable viral load.
  • Uncontrolled hepatitis B or C.
  • Recent history of blood clots, heart attack, or severe heart disease.
  • Pregnant or breastfeeding women.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Recent use of certain medications or treatments, such as ruxolitinib or immune checkpoint inhibitors.
  • History of certain heart conditions.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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