Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
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.
Timeline
- Start
- 2023-03-14
- Primary completion
- 2024-05-08
- Completion
- 2024-05-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 7 mg/kg | Intravenous |
| Subject | Fludarabine | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Ruxolitinib | Small molecule | — | Oral |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |
| Background | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Cyclosporine | Peptide | 3 mg/kg | — |
| Background | Methotrexate | Small molecule | 10 mg/m2 | Intravenous |
| Background | Thiotepa | Other / unclassified | 10 mg/kg | Intravenous |