Ruxolitinib In GvHD

• Status: Terminated
• Trial end date: 2019-11-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Nikolas von Bubnoff
• Collaborator: Clinical Trials Unit Freiburg

Criteria

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:

1. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment

2. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment

3. Failure to taper the prednisone/prednisolone dose 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

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 <0.5x103/µl

7. Evidence of transplant-associated micrioangiopathy (TAM) (According to Jodele et al., 2015, diagnostic criteria for 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