Patients who have Acute Myeloid Leukaemia (AML) or Myelodysplasia (MDS) will be recruited to this trial MedDRA version: 14.1 Level: LLT Classification code 10028532 Term: Myelodysplasia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10000880 Term: Ac
Conditions
Interventions
Trade Name: Vidaza
Product Name: 5-azacitidine
Pharmaceutical Form: Powder for solution for injection
Trade Name: Epilim 500 Enteric Coated: Epilim 200
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Satisfy WHO criteria for diagnosis of AML or high risk MDS 2) Relapsed/refractory AML/high risk MDS 3) de novo AML aged over 70 4) High risk MDS/AML in whom intensive chemotherapy is not clinically indicated 5) Age equal or greater than 18 years 6) WHO performance status 0,1,2 7) Able to swallow capsules 8) At least 2 weeks from previous chemotherapy 9) Men and women to practive effective contraception 10) Women of child bearing potential must have a negative pregnancy test 11) Aspartate transaminase/alanine aminotransaminases, total bilirubin, alk phosphatase less than or equal to 2.5 times the upper limit of normal 12) Calculated creatinine clearance greater than or equal to 50 ml/min 13) Written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications to receiving sodium valproate, ATRA or 5-azacitidine will be excluded 2) Patients who are high medical risks because of non-malignant systemic disease and those with active uncontrolled infection 3) Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the trial 4) Pregnant or lactating women 5) Patients known to be serologically positive for Hepatitis B, C or HIV 6) Concurrent congestive heart failure or prior history of New York Heart Association Class III/IV cardiac disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of four drugs sodium valproate, 5-azacitidine, theophylline and ATRA when administered in combination ; Secondary Objective: To assess the anti-leukaemic activity of four drugs, sodium valproate, 5-azacitidine, theophylline and ATRA when administered in combination in AML and high risk MDS Analyse the impact of these agents on biochemical measures of chromatin structure and cellular differentiation permitting correlation of these parameters with clinical activity of these drugs ;Primary end point(s): The primary endpoints of this study are to assess the safety and anti-leukaemic activity of four drugs sodium valproate, 5-azacitidine, ATRA, theophylline when administered in combination. | — |
Countries
United Kingdom
Outcome results
None listed