Phase II Study of the Tolerability and Efficacy of the Histone Deacetylase Inhibitor Sodium Valproate given in Conjunction with 5-azacytidine and ATRA (all trans retinoic acid ) in Patients with Acute Myeloid Leukaemia. - Val/Aza

Phase 1

• Conditions: 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: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2005-000550-75-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

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

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

Study & Design

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