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)

Phase 1

• Conditions: Steroid-refractory acute Graft-versus-Host Disease (GvHD); MedDRA version: 20.0Level: LLTClassification code 10018799Term: GVHDSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-004267-20-DE
• Lead Sponsor: Medical Center - University of Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-18
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Acute skin, intestinal (histologically confirmed) or liver GvHD > grade 1 according to standard criteria
2.Age >=18 years
3.Failure of previous treatment, defined as presence of at least one of the following criteria:
3a.Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment
3b.Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment
3c.Failure to taper the prednisone/prednisolone to 0.6 mg/kg/day or methylprednisolone dose to <0.5 mg/kg/day
4.Written informed consent
5.Ability to understand the nature of the study and the study related procedures and to comply with them
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Uncontrolled underlying disease
2.Active bleeding
3.Absence of clinical signs of acute GvHD
4.Diagnostic or distinctive clinical signs of chronic GvHD
5.Uncontrolled bacterial, viral or fungal infection
6.Absolute neutrophil count <0.5 x103/µl
7.Evidence of transplant-associated microangiopathy (TAM)
8.Any previous JAK2 inhibitor treatment prior to study enrolment, except Ruxolitinib given prior to the allogeneic stem cell transplantation
9.Known Hypersensitivity to Ruxolitinib or any of the excipients
10.Known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening.
11.Female patients who are pregnant or breast feeding
12.Concomitant use of any other investigational drug within the last thirty days before the start of this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified