drugset / Trial / NCT04872595

A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant

NCT04872595

Phase 2 Active not recruiting 59 enrolled Memorial Sloan Kettering Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to see if conditioning regimens that include personalized rabbit ATG (P-rATG) help the immune system recover sooner and decrease the chances of transplant-related side effects. Participants in this study will be children and adults who have acute leukemia or myelodysplastic syndrome (MDS), and will receive a standard conditioning regimen to prepare the body for an allogeneic hematopoietic cell transplant (allo-HCT). The conditioning regimen will include r-ATG, one of two combinations of chemotherapy, and possibly total body irradiation (TBI).

Timeline

Start
2021-04-30
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule
Subject Cyclophosphamide Other / unclassified 60 mg/kg
Subject Fludarabine Small molecule 25 mg/m2
Subject Melphalan Small molecule 70 mg/m2
Subject Thiotepa Other / unclassified 5 mg/kg