Trial to evaluate the safety and efficacy of a new drug in combination with the standard therapy to prevent the rejection which could occur after a transplantation.

Phase 1

• Conditions: Adult patiens after allogeneic stem cell transplantation; MedDRA version: 19.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 100000004870; MedDRA version: 19.1Level: LLTClassification code 10067859Term: Allogenic stem cell transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-002503-26-ES
• Lead Sponsor: Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-04
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1.Male or female patients 18 years or older.
2.Patients having received reduced intensity conditioning (RIC) peripheral blood allogeneic stem cell transplantation.
3.Patients undergoing hematopoietic stem cell transplant from a matched or a single mismatched related or unrelated donor as definition accepted by protocol.
4.Patients receiving GVHD prophylaxis with sirolimus and tacrolimus and on stable levels during the last 2 weeks before inclusion.
5.Voluntary written consent must be given before performance of any study related procedure.
6.Female patients who accomplish with requisitions for not possibility of pregnancy (menopausia, effective methods of contraception), as detailed by protocol.
7.Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
8.Patients must meet the following clinical laboratory criteria:
•Absolute neutrophil count (ANC) 1,000/mm3 and platelet count 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
•Total bilirubin 1.5 the upper limit of the normal range (ULN).
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 ULN.
•Calculated creatinine clearance 30 mL/min (see Section 11.2).
9.Ability to swallow and tolerate oral medication.
10.Absence of gastrointestinal symptoms that precludes oral intake and absorption.
11.Off antibiotics and amphotericin B formulations, voriconazole or other anti-fungal therapy for the treatment of active proven, probable or possible infections.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Female patients who are lactating or have a positive serum pregnancy test during the screening period.
2.Major surgery within 14 days before enrollment.
3.Central nervous system involvement with malignant cells.
4.Uncontrolled infection within 14 days before study enrollment.
5.Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
6.Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort.
7.Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
8.Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
9.Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
10.Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
11.Patient has Grade 1 peripheral neuropathy.
12.Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
13. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
14.Active Graft versus host disease at the time of inclusion: patients are allowed to be included if acute GVHD is in complete remission and are receiving systemic steroids at < 0.25 mg / kg.
15.Active hematologic malignancy at the time of inclusion.
16.Active microangiopathy at the time of inclusion (according to IWG criteria)
17. Gastrointestinal disease or procedure than can interfere with oral absortion , intolerance to the ixazomib or difficulty to swallow.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified