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

Sponsor
University of Cologne (Other)
Overall Status
Completed
CT.gov ID
NCT02812940
Collaborator
(none)
19
Enrollment
1
Location
1
Arm
56
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation [day 100 after transplantation]

      GvHD

    Secondary Outcome Measures

    1. Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation [day 100 after transplantation]

      GvHD

    2. Incidence of severe chronic GvHD [720 days after transplantation]

      cGvHD

    3. Incidence of overall chronic GvHD [720 days after transplantation]

      cGvHD

    4. Relapse incidence [720 days after transplantation]

      Relapse

    5. Non-relapse mortality [720 days after transplantation]

      NRM

    6. Overall survival [720 days after transplantation]

      OS

    7. Immune reconstitution [day 100 after transplantation]

      Number of CD3, CD4, CD8, CD20 and CD56 positive cells in peripheral blood

    8. Engraftment [day 100 after transplantation]

      absolute neutrophil count > 500/ul and platelet count > 50.000/ul

    9. Chimerism [day 100 after transplantation]

      % donor cells in peripheral blood or bone marrow

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cologne Cologne Germany 50924

    Sponsors and Collaborators

    • University of Cologne

    Investigators

    • Principal Investigator: Christof Scheid, Prof. Dr., University of Cologne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christoph Scheid, Prof. Dr. Christoph Scheid, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT02812940
    Other Study ID Numbers:
    • Uni-Koeln 1717
    First Posted:
    Jun 24, 2016
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Graft vs Host Disease
    Everolimus

    Study Results

    No Results Posted as of Mar 17, 2021