drugset / Trial / NCT03225417

Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.

NCT03225417

RandomizedParallel-groupOpen-labelTreatment

Summary

Allogeneic hematopoietic stem cell transplantation (HTC) is the only curative option for many patients with hematologic malignancies but \>50% of this patients will develop extensive chronic graft-versus-host disease (cGVHD), which remains the most important complication after HTC. Classically, the most effective strategies to prevent GVHD have not improved survival; therefore, the new strategies are being sought. This study is designed in two phases: the main objective for phase I study is the more suitable dose for ixazomib search. Phase II study is designed to evaluate the efficacy of ixazomib at the doses stablished in phase I.

Timeline

Start
2017-05-16
Primary completion
2024-01-11
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ixazomib Unknown 3 mg Oral
Subject Ixazomib Unknown 4 mg Oral
Background Sirolimus Small molecule 4 mg Oral
Background Tacrolimus Small molecule 0.06 mg/kg