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Ruxolitinib In GvHD

NCT02396628 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-12-02

No results posted yet for this study

Summary

The preliminary data demonstrate potent activity of Ruxolitinib in steroid-refractory aGvHD. In this phase 2 trial the efficacy of Ruxolitinib and best available treatment (BAT) versus BAT in steroid-refractory acute GvHD in approximately 12 transplantation centers in Germany will be compared. The response by monitoring the clinical GvHD grade, requirement of alternative GvHD active agents and serum levels of pro-inflammatory cytokines will be determined.

Conditions

  • Graft vs Host Disease

Interventions

DRUG

Experimental intervention

Treatment with Ruxolitinib at a dose of 10 mg BID orally addition to BAT according DGHO-Onkopedia guidelines

DRUG

Standard treatment

Treatment according to DGHO-Onkopedia guidelines for treatment of acute GvHD (as of March 2018). Optional cross over from BAT to Ruxolitinib and BAT in case of lack of response from day 28.

Sponsors & Collaborators

  • Clinical Trials Unit Freiburg

    collaborator OTHER

  • Prof. Dr. Nikolas von Bubnoff

    lead OTHER

Principal Investigators

  • Nikolas von Bubnoff, Professor · Medical Center - University of Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2019-11-15
Completion
2019-11-15

Countries

  • Germany

Study Locations

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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 NCT02396628 on ClinicalTrials.gov