NCT02396628

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 29, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

2.4 years

First QC Date

March 10, 2015

Last Update Submit

November 27, 2019

Conditions

Graft vs Host Disease

Keywords

Graft-versus-Host Disease (GvHD)resistance to therapyallogeneic stem cell transplantationRuxolitinib

Outcome Measures

Primary Outcomes (1)

  • efficacy of Ruxolitinib and BAT as compared to BAT alone at day 28 after randomisation

    To evaluate efficacy of Ruxolitinib and BAT as compared to BAT alone at day 28 after randomisation start in steroid-refractory acute GvHD, measured as response rate

    at day 28 after randomisation

Study Arms (2)

Experimental intervention

EXPERIMENTAL

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

Drug: Experimental intervention

Standard treatment

ACTIVE COMPARATOR

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.

Drug: Standard treatment

Interventions

Experimental interventionDRUG

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

Experimental intervention
Standard treatmentDRUG

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.

Standard treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute skin, intestinal (histologically confirmed) or liver GvHD \> grade 1 according to standard criteria
  • Age ≥18 years
  • Failure of previous treatment, defined as presence of at least one of the following criteria:
  • Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment
  • Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment
  • Failure to taper the prednisone/prednisolone dose to \<0.6 mg/kg/day or methylprednisolone dose to \<0.5 mg/kg/day
  • Written informed consent
  • Ability to understand the nature of the study and the study related procedures and to comply with them

You may not qualify if:

  • Uncontrolled underlying disease
  • Active bleeding
  • Absence of clinical signs of acute GvHD
  • Diagnostic or distinctive clinical signs of chronic GvHD
  • Uncontrolled bacterial, viral or fungal infection
  • Absolute neutrophil count \<0.5x103/µl
  • Evidence of transplant-associated micrioangiopathy (TAM) (According to Jodele et al., 2015, diagnostic criteria for TAM)
  • Any previous JAK2 inhibitor treatment prior to study enrolment, except Ruxolitinib given prior to the allogeneic stem cell transplantation
  • Known Hypersensitivity to Ruxolitinib or any of the excipients
  • Known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening.
  • Female patients who are pregnant or breast feeding
  • Concomitant use of any other investigational drug within the last thirty days before the start of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

University Medical Center

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitätsklinikum Marburg

Marburg, 35043, Germany

Location

Universitätsklinikum München TU rechts der Isar

München, 81675, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Related Publications (1)

  • von Bubnoff N, Ihorst G, Grishina O, Rothling N, Bertz H, Duyster J, Finke J, Zeiser R. Ruxolitinib in GvHD (RIG) study: a multicenter, randomized phase 2 trial to determine the response rate of Ruxolitinib and best available treatment (BAT) versus BAT in steroid-refractory acute graft-versus-host disease (aGvHD) (NCT02396628). BMC Cancer. 2018 Nov 19;18(1):1132. doi: 10.1186/s12885-018-5045-7.

    PMID: 30453910DERIVED

Related Links

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Nikolas von Bubnoff, Professor

    Medical Center - University of Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 24, 2015

Study Start

June 29, 2017

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

December 2, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(11)