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Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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
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.
Tacrolimus
Tacrolimus at dose of 0.02 mg/kg/day and then 0.06 mg/kg/day.
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.
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