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

• Status: Not yet recruiting
• Trial end date: 2027-04-01

Summary

The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant.

Primary Objectives

To estimate the incidence of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calcineurin inhibitors after day +60 post first allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor HCT for hematological malignancies.

Secondary objective

Determine the cumulative incidence of relapse, NRM, chronic GVHD, and OS in study participants at one year post-transplant.

Exploratory objectives

• To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) profiles of ruxolitinib, fludarabine, and rATG.

• To assess immune reconstitution in study participants within the first year post-HCT.

• Phase: Phase 2

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Methotrexate; Thiotepa; Thymoglobulin