NCT03225417

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

Phase Ib/II Trial to Evaluate Safety and Efficacy of Oral Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study design is based on a phase I / II trial in eight Spanish hospitals. In the phase I, a number of 3 to 12 patients will be included to evaluate the optimal dose of ixazomib in combination with sirolimus and tacrolimus. In the phase II, a total number of 130 patients will be randomized to receive ixazomib or the best medical recommendation added in order to evaluate the efficacy of ixazomib. This patients who will receive any prophylaxis for GVHD, except those patients who received antithymocyte globulin , cyclophosphamide or any T depletion protocol in vitro or in vivo.

Conditions

• Hematopoietic Stem Cell Transplantation
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	Ixazomib capsules. Phase I: Starting dose of Ixazomib: 3.0 or 4.0 mg by day +1, +8 and +15. Phase II: Starting Dose of Ixazomib: Maximum tolerated dose from Phase I.
DRUG	Tacrolimus	Tacrolimus at dose of 0.02 mg/kg/day and then 0.06 mg/kg/day.
DRUG	Sirolimus	Sirolimus oral solution. Standing 6 mg orally on day -5 and continued 4mg per day. This drugs should be slowly tapered starting 3 months posttransplant in order to stop them at 9 to 12 months posttransplant according to physician criteria.
DRUG	Any prophylaxis for GVHD	Except antithymocyte globulin, cyclophosphamide or any T depletion protocol in vitro or in vivo.

Timeline

• Start date: 2017-05-16
• Primary completion: 2024-01-11
• Completion: 2024-12-31
• First posted: 2017-07-21
• Last updated: 2024-08-30

Locations

8 sites across 1 country: Spain