Phase Ib/II trial to evaluate safety and efficacy of oral ixazomib in combination with sirolimus and tacrolimus in the prophylaxis of chronic graft-versus-host disease

Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)0 sites152 target enrollmentJanuary 4, 2017

ConditionsAdult 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]

DrugsNinlaro RAPAMUNE PROGRAF

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Adult patiens after allogeneic stem cell transplantation
Sponsor: Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
Enrollment: 152
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 4, 2017

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)

Eligibility Criteria

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).

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.