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

Graft-versus-Host Disease Clinical Trial

— OCTET-Ever  

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 Details — Status: Completed

Administrative data

• NCT number: NCT02812940
• Other study ID #: Uni-Koeln 1717
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-Host Disease

Intervention

Drug:
• Everolimus
GvHD prophylaxis

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

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