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ACTIVE NOT RECRUITING
NCT03225417
PHASE1/PHASE2

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

Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2017-05-16

Completion Date

2024-12-31

Last Updated

2024-08-30

Healthy Volunteers

No

Interventions

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.

Locations (8)

ICO- Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitario Vall D´Hebrón

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clinico Universitario Salamanca

Salamanca, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain