EUCTR2014-005659-19-GB
Active, not recruiting
Not Applicable
A phase II study of the use of azacitidine for the treatment of patients with chronic graft-versus-host-disease who have failed therapy with corticosteroids - AZTEC
ConditionsChronic Graft versus Host DiseaseMedDRA version: 18.1Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsVidaza
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Graft versus Host Disease
- Sponsor
- niversity of Birmingham
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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