OncoMatch/Clinical Trials/NCT06128070
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
Is NCT06128070 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Methotrexate and Ruxolitinib Phosphate for acute lymphoblastic leukemia.
Treatment: Methotrexate · Ruxolitinib Phosphate · Tacrolimus — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG/KARNOFSKY/LANSKY 0–2
ECOG ≤ 2; Karnofsky ≥ 60% for patients ≥ 16 years old OR Lansky status ≥ 60% for patients < 16 years old
Prior therapy
Cannot have received: autologous stem cell transplant
Autologous stem cell transplant within 1 year prior to day 1 of protocol therapy
Cannot have received: allogeneic transplantation
Prior allogeneic transplantation
Cannot have received: chemotherapy
Exception: maintenance chemotherapy with agents listed are not excluded; conditioning regimen within 21 days prior to day 1 of protocol therapy is not considered as an exclusion criterion
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: radiation therapy
Exception: conditioning regimen within 21 days prior to day 1 of protocol therapy is not considered as an exclusion criterion
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: biological therapy
Exception: conditioning regimen within 21 days prior to day 1 of protocol therapy is not considered as an exclusion criterion
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Cannot have received: immunotherapy
Exception: conditioning regimen within 21 days prior to day 1 of protocol therapy is not considered as an exclusion criterion
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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