A Randomised Phase II trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with relapsed Acute Myeloid Leukaemia ineligible for intensive chemotherapy

• Conditions: Haematological Malignancy - Acute Myeloid Leukaemia; MedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005207-32-GB
• Lead Sponsor: The University of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-28
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

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

Inclusion Criteria

1) Adults with AML in first relapse (except Acute Promyelocytic Leukaemia (APL) as defined by the World Health Organisation (WHO) Classification) who are deemed ineligible for intensive chemotherapy on the grounds of age or co-morbidities 2)Patients must have achieved a previous morphological CR as defined by Cheson criteria after treatment with conventional myelosuppressive chemotherapy e.g. anthracycline, ara-C, etoposide containing regimens 3)Patients are able to receive treatment as an out-patient 4)Adequate renal and hepatic function 5)Patients have given written informed consent 6)ECOG performance status =2
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

1)Patients with greater than class III of the New York Heart Association (NYHA) cardiac impairment 2)Blastic transformation of Chronic Myeloid Leukaemia (CML) 3)Any concurrent active malignancy 4)Prior allogeneic/autologous haematopoietic stem cell transplant (HSCT) 5)Pregnant or lactating women (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the start of treatment) 6) Adults of reproductive potential not willing to use appropriate medically approved contraception during the trial and for specified amount of time afterwards. 8)Patients who have received prior HDAC inhibitor-like treatment as anti-tumour therapy. (Patients who have received HDACi treatment for other indications e.g valproic acid for epilepsy may enrol after a 30-day washout period). 9)Previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 30 days before the start of protocol treatment 10)Patients who have received prior treatment with demethylating agents such as 5-azacitidine or decitabine 11)Patients with contraindications to receiving azacitidine or vorinostat such as hypersenstivity or patients unable to receive subcutaneous injection 12)Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis. 13)Any co-morbidity that could limit compliance with the trial

Study & Design

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