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