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Single-centre Study of Everolimus as GvHD Prophylaxis After Post-Transplantation Cyclophosphamide After Allogeneic SCT — OCTET-Ever  

Graft-versus-Host Disease Clinical Trial

Official title:
A Single-centre Study of Certican (Everolimus) as Prophylaxis for Graft-versus-Host Disease Following Post-Transplantation Cyclophosphamide After Allogeneic Stem Cell Transplantation

Clinical Trial Summary

A phase II clinical study to assess the efficacy of short-term everolimus as prophylaxis for Graft-versus-Host disease (GvHD) in addition to post-transplantation cyclophosphamide after allogeneic hematopoietic stem cell transplantation in patients with haematological malignancies

Clinical Trial Description

Title of the clinical study: A single-centre study of Certican (everolimus) as Prophylaxis for Graft-versus-Host Disease following Post-Transplantation Cyclophosphamide after Allogeneic Stem Cell Transplantation (OCTET-EVER) Indication: Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide Phase: Phase II clinical study Type of study, study design, methodology: Single centre single arm clinical trial, A'Hern's single stage phase II procedure Number of subjects: 20 (17 total evaluable) Primary study objective To assess the efficacy of short-term everolimus as GvHD prophylaxis in addition to post-transplantation cyclophosphamide after allogeneic hematopoietic stem cell transplantation in patients with haematological malignancies and to describe the influence of the modified immunosuppression concept on the incidence and severity of acute GvHD, relapse rates, minimal residual disease, immune reconstitution and chimerism. Medical condition or disease to be investigated: • Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide Name of investigational medicinal product (IMP): Everolimus (Certican®) Investigational medicinal product - dosage and method of administration: 1,5mg per os twice a day (target blood level 5 to 10ng/ml) from day +5 to day +100 after allogeneic stem cell transplantation Duration of treatment: The treatment will be given from day +5 to day +100 after allogeneic stem cell transplantation. The observation time will last from day +5 to day +130. Incidence of chronic GvHD, overall survival and relapse incidence will be recorded on d+365 and d+720 after transplant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02812940
Study type Interventional
Source University of Cologne
Contact
Status Completed
Phase Phase 2
Start date April 2016
Completion date December 2020
View Details
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