A Phase 2 interventional study of Everolimus in Graft-versus-Host Disease, sponsored by University of Cologne. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by University of Cologne · Phase 2, Interventional, and Prevention
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
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:
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.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 19 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.
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Principal inclusion criteria:
Exclusion Criteria:
Everolimus from day +5 to day +100
Drug: Everolimus
GvHD prophylaxis
Also known as: Certican
Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation
GvHD
Time frame: day 100 after transplantation
Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation
GvHD
Time frame: day 100 after transplantation
Incidence of severe chronic GvHD
cGvHD
Time frame: 720 days after transplantation
Incidence of overall chronic GvHD
cGvHD
Time frame: 720 days after transplantation
Relapse incidence
Relapse
Time frame: 720 days after transplantation
Non-relapse mortality
NRM
Time frame: 720 days after transplantation
Overall survival
OS
Time frame: 720 days after transplantation
Immune reconstitution
Number of CD3, CD4, CD8, CD20 and CD56 positive cells in peripheral blood
Time frame: day 100 after transplantation
Engraftment
absolute neutrophil count \> 500/ul and platelet count \> 50.000/ul
Time frame: day 100 after transplantation
Chimerism
% donor cells in peripheral blood or bone marrow
Time frame: day 100 after transplantation
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Cologne