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CN160: Ruxolitinib Therapy in Children after Bone Marrow Transplant

About this study

When you get a transplant, the transplanted cells from another person’s body (donor cells) see your body as different, and they try to fight your body. As these donor cells fight your body, you may get symptoms that make you quite sick. These symptoms are known as graft-versus-host disease (GVHD). GVHD symptoms can happen almost anywhere in your body. They can happen right away or later. To decrease the chance of getting GVHD, doctors usually give patients drugs called cyclosporine A (CsA) until 100 days after the transplant, and methotrexate.

CsA has many side effects that increase the risk of complications. CsA also affects how donor lymphocytes kill leukemia cells. We hope to add a new drug called ruxolitinib to therapy after transplant. The use of this drug would lower the amount of CsA you receive. The FDA has approved ruxolitinib for the treatment of bad cases of GVHD.

Instead of giving CsA until 100 days after transplant, doctors would like to give it until only 60 days after transplant. They will add ruxolitinib beginning the 40th day after transplant and continue giving it until the 100th day.

Ruxolitinib works differently than CsA, and patients tolerate it well. It does not affect how donor lymphocytes kill leukemia cells. We will test the combination of CsA with methotrexate and ruxolitinib to see if GVHD symptoms decrease.

Eligibility overview

  • A high-risk hematologic malignancy that requires a bone marrow transplant
  • Ages 12–21 years
  • A related or unrelated donor
  • Free of severe infection
  • Adequate heart, liver, kidney, and lung function
  • Not pregnant

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Overview

Full title:

A Phase II Pediatric Study of a Graft-vs.-host disease (GVHD) prophylaxis regimen with no calcineurin inhibitors after day +60 post first allogeneic hematopoietic cell transplant for hematological malignancies

Study goal:

The main purpose of this study is to find out if it is safe to stop CsA early and use a new drug called ruxolitinib instead.

Diagnosis:

Acute lymphoblastic leukemia, acute myeloid leukemia, Myelodysplastic syndromes, Hodgkin lymphoma, Non-Hodgkin lymphoma, juvenile myelomonocytic leukemia

Age:

Ages 12-21 years

Clinical trials categories:

Hodgkin Lymphoma Juvenile Myelomonocytic Leukemia Acute Myeloid Leukemia (AML) Childhood Cancer Lymphoma Leukemia Myelodysplastic Syndromes Non-Hodgkin Lymphoma Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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