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

NCT02812940 | Completed Phase 2

• 1 other identifier: Uni-Koeln 1717
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Graft-versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation

  GvHD

  day 100 after transplantation

Secondary Outcomes (9)

• Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation

  day 100 after transplantation

• Incidence of severe chronic GvHD

  720 days after transplantation

• Incidence of overall chronic GvHD

  720 days after transplantation

• Relapse incidence

  720 days after transplantation

• Non-relapse mortality

  720 days after transplantation

Study Arms (1)

Everolimus as part of GvHD prophylaxis after allogeneic SCT

EXPERIMENTAL

Everolimus from day +5 to day +100

Drug: Everolimus

Interventions

Everolimus DRUG

GvHD prophylaxis

Also known as: Certican

Everolimus as part of GvHD prophylaxis after allogeneic SCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University of Cologne

Cologne, 50924, Germany

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Christof Scheid, Prof. Dr.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Christoph Scheid

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: June 24, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)