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Phase I: Ixazomib + Tacrolimus + Sirolimus. Ixazomib doses in this study is 3 to 4 mg of ixazomib on day +1, +8 and +15. Tacrolimus at a dose of 0.02 mg/kg/day and then 0.06 mg/kg/day. Sirolimus at a dose of 6 mg on day -5 and then 4 mg per day.

Phase II: Ixazomib+ any prophylaxis for GVHD, except antithymocyte globulin, cyclophosphamide or any T depletion protocol in vitro or in vivo.

Starting Dose of Ixazomib according to phase I.

Any prophylaxis for GVHD, except antithymocyte globulin, cyclophosphamide or any T depletion protocol in vitro or in vivo.

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 at dose of 0.02 mg/kg/day and then 0.06 mg/kg/day.

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.

Except antithymocyte globulin, cyclophosphamide or any T depletion protocol in vitro or in vivo.

Any prophylaxis for GVHD

Jose-Antonio Perez-Simon, MD-PhD

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.

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.

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.

Anonymized data for primary and secondary variables is planned to be shared with all participants within 6 months of data completion.

Maximun tolerated dose of the ixazomib in combination with sirolimus and tacrolimus in patients following allogeneic stem cell transplantation for the phase I study will be determinated

Presence of moderate plus severe Chronic Graft-versus-host Disease according to NIH scale in patients receiving the maximum tolerated dose.

Quantification of time of event immune recovery in patients exposed and not exposed to ixazomib.

Quantification of time of event free survival for patients receiving the maximum tolerated dose.

Evaluation of needs of additional permitted immunosuppressive treatment administered as concomitant medication

Quantification of time of overall survival after study treatment

Describe the serious adverse event notified during the study

To evaluate the risk of moderate or severe GVHD according to the NIH scale

To evaluate differences in terms of chronic GVHD and treatment tolerance

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.	NCT03225417	Hematopoietic S... Multiple Myelom...	Ixazomib Tacrolimus Sirolimus Any prophylaxis...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.	NCT03225417	Hematopoietic S... Multiple Myelom...	Ixazomib Tacrolimus Sirolimus Any prophylaxis...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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