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

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ClinicalTrials.gov Identifier: NCT02812940
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Christoph Scheid, University of Cologne

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
Graft-versus-Host Disease Drug: Everolimus 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019


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 Name: Certican




Primary Outcome Measures :
  1. Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation [ Time Frame: day 100 after transplantation ]
    GvHD


Secondary Outcome Measures :
  1. Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation [ Time Frame: day 100 after transplantation ]
    GvHD

  2. Incidence of severe chronic GvHD [ Time Frame: 720 days after transplantation ]
    cGvHD

  3. Incidence of overall chronic GvHD [ Time Frame: 720 days after transplantation ]
    cGvHD

  4. Relapse incidence [ Time Frame: 720 days after transplantation ]
    Relapse

  5. Non-relapse mortality [ Time Frame: 720 days after transplantation ]
    NRM

  6. Overall survival [ Time Frame: 720 days after transplantation ]
    OS

  7. Immune reconstitution [ Time Frame: day 100 after transplantation ]
    Number of CD3, CD4, CD8, CD20 and CD56 positive cells in peripheral blood

  8. Engraftment [ Time Frame: day 100 after transplantation ]
    absolute neutrophil count > 500/ul and platelet count > 50.000/ul

  9. Chimerism [ Time Frame: day 100 after transplantation ]
    % donor cells in peripheral blood or bone marrow



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812940


Contacts
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Contact: Christof Scheid, Prof. Dr. +49221478 ext 6296 c.scheid@uni-koeln.de
Contact: Udo Holtick, PD Dr. Dr. +49221478 ext 4407 udo.holtick@uk-koeln.de

Locations
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Germany
University of Cologne Recruiting
Cologne, Germany, 50924
Contact: Christoph Scheid, MD PhD    49221478 ext 6296    c.scheid@uni-koeln.de   
Sub-Investigator: Udo Holtick, MD         
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Christof Scheid, Prof. Dr. University of Cologne

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Responsible Party: Christoph Scheid, Prof. Dr. Christoph Scheid, University of Cologne
ClinicalTrials.gov Identifier: NCT02812940     History of Changes
Other Study ID Numbers: Uni-Koeln 1717
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Sirolimus
Cyclophosphamide
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents