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

March 16, 2021 updated by: Christoph Scheid, University of Cologne

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50924
        • University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Principal inclusion criteria:

• Written informed consent

Exclusion Criteria:

  • Known intolerance to everolimus
  • Presence or history of Microangiopathy
  • Presence of uncontrolled infections
  • Severe organ dysfunction defined as:
  • Cardiac left ventricular ejection fraction (LVEF) of less than 35%
  • Diffusing lung capacity (DLCO) of less than 40%
  • Total lung capacity (TLC) of less than 40%
  • Forced expiratory volume (FEV1) of less than 40%
  • Total bilirubin >3mg/dl
  • Creatinine-clearance of less than 40 ml/min
  • Pregnancy or breast feeding
  • Participation in other experimental drug trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Everolimus as part of GvHD prophylaxis after allogeneic SCT
Everolimus from day +5 to day +100
Drug: Everolimus
GvHD prophylaxis
Other Names:
  • Certican

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation
Time Frame: day 100 after transplantation
GvHD
day 100 after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation
Time Frame: day 100 after transplantation
GvHD
day 100 after transplantation
Incidence of severe chronic GvHD
Time Frame: 720 days after transplantation
cGvHD
720 days after transplantation
Incidence of overall chronic GvHD
Time Frame: 720 days after transplantation
cGvHD
720 days after transplantation
Relapse incidence
Time Frame: 720 days after transplantation
Relapse
720 days after transplantation
Non-relapse mortality
Time Frame: 720 days after transplantation
NRM
720 days after transplantation
Overall survival
Time Frame: 720 days after transplantation
OS
720 days after transplantation
Immune reconstitution
Time Frame: day 100 after transplantation
Number of CD3, CD4, CD8, CD20 and CD56 positive cells in peripheral blood
day 100 after transplantation
Engraftment
Time Frame: day 100 after transplantation
absolute neutrophil count > 500/ul and platelet count > 50.000/ul
day 100 after transplantation
Chimerism
Time Frame: day 100 after transplantation
% donor cells in peripheral blood or bone marrow
day 100 after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

June 19, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (ESTIMATE)

June 24, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln 1717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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