A phase II study of the use of azacitidine for the treatment of patients with chronic graft-versus-host-disease who have failed treatment with corticosteroids

• Conditions: Chronic Graft versus Host Disease; MedDRA version: 18.1Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-005659-19-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-09
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with moderate or severe cGvHD OR progressive, recurrent or delayed-onset acute GvHD as defined by the NIH Consensus Conference Diagnostic Criteria who have failed therapy with corticosteroids (+/- calcineurin inhibitors).
Failure of corticosteroid is defined as either:
o progression of cGvHD on 1mg/kg/day prednisolone over 2 weeks
o stable cGvHD on =0.5mg/kg/day prednisolone over 4 weeks
o inability to taper prednisolone below 0.5mg/kg/day without recurrence of clinical manifestations
o inability to tolerate first line therapy* (eg steroid myopathy, calcineurin inhibitor-induced renal toxicity)
*Patients must have proven steroid toxicity to meet this criterion for having failed corticosteroid therapy. These cases must be discussed with the Chief Investigator prior to trial entry.
• Patients must be unable to receive treatment with extracorporeal photophoresis (ECP) therapy (either refractory/intolerant to ECP, lack of ECP availability at local institution or patient/physician preference)
• Age =16 years of age
• Life expectancy of at least 3 months with no imminent relapse expected
• Women of childbearing potential and all men must be using adequate birth control measures throughout the study and for a minimum of 3 months following the end of trial treatment
• Able to provide written informed consent
• Patients must be able to comply with all study procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

• Uncontrolled infection = grade 3 requiring treatment at study entry
• Neutrophil count <1x109/L (support with GCSF permitted)
• Platelet count <30 x109/L
• Known HIV infection
• Known hepatitis B or C
• ECOG = 3
• Patients with ocular GvHD only
• Pulmonary GvHD
• Patients receiving active therapy for cGvHD within 14 days of study entry (with the exception of corticosteroids and calcineurin inhibitors)
• Any investigational agents within 14 days of study entry
• Treatment with ECP within 6 months of study entry
• Known hypersensitivity to azacitidine
• Women who are pregnant or breastfeeding
• Any other condition that in the Investigator's opinion will affect the patient's participation in this trial

Study & Design

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