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RECRUITING
NCT06128070
PHASE2

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 22 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-07-16

Completion Date

2030-11-22

Last Updated

2025-10-31

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Chest Computed Tomography

Undergo chest CT

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Hematopoietic Cell Transplantation

Undergo HCT

DRUG

Methotrexate

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Ruxolitinib Phosphate

Given PO

DRUG

Tacrolimus

Given IV

Locations (1)

City of Hope Medical Center

Duarte, California, United States