drugset / Trial / NCT03225417
Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.
Phase 1/2
Active not recruiting
142 enrolled
Andalusian Public Foundation for Health Research in Seville
Spanish Clinical Research Network - SCReN · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |