drugset
drugset / Trial / NCT02867800

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

NCT02867800 ↗

Phase 1 Completed 24 enrolled Monica Bhatia
NaSingle-groupOpen-labelTreatment

Summary

To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-Ig) when added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine, thiotepa, melphalan, and alemtuzumab for conditioning.

Timeline

Start
2016-07
Primary completion
2021-12-30
Completion
2023-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 10 mg/kg Intravenous
Background Acetaminophen Small molecule 10 mg/kg Oral
Background Acetaminophen Small molecule 15 mg/kg Oral
Background Alemtuzumab Monoclonal antibody 20 mg/m2 Intravenous
Background Cyclosporine Peptide — —
Background Diphenhydramine Unknown 1 mg/kg Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Melphalan Small molecule 140 mg/m2 Intravenous
Background Meperidine Unknown 0.5 mg/kg Intravenous
Background Methotrexate Small molecule 10 mg/m2 Intravenous
Background Methylprednisolone Other / unclassified 0.25 mg/kg Intravenous
Background Methylprednisolone Other / unclassified 0.5 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule — —
Background Sirolimus Small molecule — —
Background Tacrolimus Small molecule — —
Background Thiotepa Other / unclassified 8 mg/kg Intravenous
Background Thymoglobulin Protein / enzyme biologic 4 mg/kg —

Indications

graft versus host disease sickle cell disease