drugset / Trial / NCT01926899

A Multicenter Phase I Study Evaluating the Addition of Bortezomib to an Established Acute Graft Versus Host Disease Prophylaxis Regimen in Pediatric Allogeneic Hematopoietic Stem Cell Transplant Patients

NCT01926899 ↗

Phase 1 Completed 15 enrolled Indiana University
NaSingle-groupOpen-labelPrevention

Summary

The objective of this study is to determine the maximum tolerated dose (MTD) of bortezomib in combination with calcineurin inhibitor and methotrexate as acute graft versus host disease (aGVHD) prophylaxis in pediatric patients undergoing allogeniec hematopoietic stem cell transplant (alloHSCT)

Timeline

Start
2013-08-01
Primary completion
2018-02-01
Completion
2018-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 0.7 mg/m2 —