Study on Ruxolitinib with Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease in Young Patients Undergoing Bone Marrow Transplant for Leukemia or Myelodysplastic Syndrome

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06128070

Provider View

This clinical trial is testing whether a combination of three drugs—Ruxolitinib, Tacrolimus, and Methotrexate—can help prevent graft versus host disease (GVHD) in children and young adults receiving a bone marrow transplant for certain blood cancers.

Patient Parameters

Program Overview

The purpose of this study is to see if using Ruxolitinib along with Tacrolimus and Methotrexate can prevent graft versus host disease (GVHD) in young patients undergoing a bone marrow transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib helps block signals that cause inflammation, Tacrolimus reduces the risk of transplant rejection, and Methotrexate helps stop cancer cells from growing and also suppresses the immune system. This combination may help prevent GVHD in these patients.

Description

The main goals of this study are to determine if adding Ruxolitinib to Tacrolimus and Methotrexate is safe for young patients undergoing a bone marrow transplant and to see how well this combination works in preventing GVHD. The study will also look at how often GVHD occurs, survival rates, and any side effects or complications from the treatment.

Participants will take Ruxolitinib by mouth twice a day from one day before the transplant to 100 days after. They will also receive Tacrolimus and Methotrexate through an IV on specific days around the time of the transplant. The transplant itself will occur on day 0. Throughout the study, participants will have various tests, including blood samples and scans, to monitor their health and the treatment's effects.

After finishing the treatment, participants will have follow-up visits at 30 days, 1 year, and 2 years after the transplant to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Ages 2 to 22 years old.
  • Must be in good health with a performance status score of 60% or higher.
  • Eligible for a bone marrow transplant from a matched donor.
  • Diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome in remission.
  • Must have recovered from previous cancer treatments.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control during the study and for 6 months after.
  • Must agree to allow the use of previous tumor biopsy samples if available.

Exclusion Criteria

  • Have had a previous bone marrow transplant or certain other treatments within the past year.
  • Currently taking certain medications or herbal supplements.
  • Have a history of severe allergic reactions to similar drugs.
  • Have active infections or other serious health conditions.
  • Have a history of blood clots or certain other medical conditions.
  • Pregnant or breastfeeding women.
  • Any condition that might make it unsafe to participate in the study or make it difficult to follow the study procedures.

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