Overview

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

Status:
Completed
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Cologne
Treatments:
Cyclophosphamide
Everolimus
Sirolimus
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