RecruitingPhase 2NCT06128070

Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

Phase 2a Study of Adding Ruxolitinib With Tacrolimus/Methotrexate Regimen for Graft-versus-Host Disease Prophylaxis in Myeloablative Conditioning Hematopoietic Cell Transplantation in Pediatric and Young Adult Patients


Sponsor

City of Hope Medical Center

Enrollment

40 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well ruxolitinib with tacrolimus and methotrexate work to prevent the development of graft versus host disease in pediatric and young adult patients undergoing allogeneic hematopoietic cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib is a type of medication called a kinase inhibitor. It works by blocking the signals of cells that cause inflammation and cell proliferation, which may help prevent graft versus host disease (GVHD). Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants by suppressing the immune system. Methotrexate stops cells from making DNA, may kill cancer cells, and also suppress the immune system, which may reduce the risk of GVHD. Giving ruxolitinib with tacrolimus and methotrexate may prevent GVHD in pediatric and young adults undergoing allogeneic hematopoietic cell transplants.


Eligibility

Min Age: 2 YearsMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding Ruxolitinib (a drug that reduces inflammation) to the standard medications Tacrolimus and Methotrexate can better prevent graft-versus-host disease (GVHD) — a serious complication where donated immune cells attack the patient's body — in children and young adults receiving bone marrow transplants for leukemia or a blood disorder called myelodysplastic syndrome. **You may be eligible if:** - You are 2–22 years old and weigh at least 25 kg - You have been diagnosed with AML (acute myeloid leukemia), ALL (acute lymphoblastic leukemia), or MDS (myelodysplastic syndrome) - You are in complete remission from your leukemia - You have a suitable matched bone marrow donor (related or unrelated) - Your physical functioning is adequate (Karnofsky/Lansky score at least 60%) **You may NOT be eligible if:** - You have had a prior bone marrow transplant - You have had an autologous (self) stem cell transplant within the past year - You have active tuberculosis or a history of blood clots (heart attack, stroke, DVT, pulmonary embolism) within 6 months - You have active HIV, hepatitis B, or hepatitis C - You have another active cancer besides the one being treated - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREChest Computed Tomography

Undergo chest CT

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREHematopoietic Cell Transplantation

Undergo HCT

DRUGMethotrexate

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGRuxolitinib Phosphate

Given PO

DRUGTacrolimus

Given IV


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06128070


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