MedTrace Logo

Treatment of Newly Diagnosed Moderate or Severe Chronic Graft-versus-host Disease With Prednisone and Everolimus

NCT01862965 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-04-02

No results posted yet for this study

Summary

In this study patients with moderate to severe chronic graft-versus-host disease will be treated with a combination of prednisone and everolimus. Patients will be treated on the study for a maximum of 12 months and followed up for another 12 months.

The primary hypothesis of this study is that the addition of everolimus to prednisone increases response rates without increasing treatment related mortality or mortality due to relapse of underlying disease.

Conditions

  • Chronic Graft-versus-host Disease

Interventions

DRUG

PredEver

Firstline treatment with prednisone and Everolimus

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Crolll Gmbh

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-06
Primary Completion
2018-02-07
Completion
2019-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01862965 on ClinicalTrials.gov