Condition category
Cancer
Date applied
29/06/2012
Date assigned
29/06/2012
Last edited
16/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Nadira Jilani

ORCID ID

Contact details

Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
-
n.y.jilani@bham.ac.uk

Additional identifiers

EudraCT number

2011-005207-32

ClinicalTrials.gov number

NCT01617226

Protocol/serial number

12452

Study information

Scientific title

Phase II randomised trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with relapsed acute myeloid leukaemia ineligible for intensive chemotherapy

Acronym

RAvVA

Study hypothesis

This is a multicentre, open-label randomised phase II trial, comparing azacitidine monotherapy with combined azacitidine and vorinostat in patients with relapsed Acute Myeloid Leukaemia (AML).

Ethics approval

NRES – West Midlands Research Ethics Committee, 12/WM/0087; First MREC approval date 21/05/2012

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute myeloid)

Intervention

Patients will be randomised on 1:1 ratio to treatment. It is anticipated 80 patients will be randomised to receive azacitidine monotherapy and 80 patients will be randomised to receive azacitidine and vorinostat, combined therapy.

Azacitidine, azacitidine (75 mg/m2) subcutaneous (s.c.) x 7 per cycle on days 1-5, 8, 9 of each 28-day cycle

Azacitidine + vorinostat:
Azacitidine (75 mg/m2) s.c. x 7 per cycle on days 1-5, 8, 9 of each 28-day cycle
Vorinostat (300mg) twice a day (bid) x 7 per cycle on days 3-9 of each 28-day cycle

Follow Up Length: 24 month(s)

Intervention type

Drug

Phase

Phase I/II

Drug names

5-Azacitidine, Vorinostat

Primary outcome measures

Overall Response Rate assessed within 6 cycles of treatment

Secondary outcome measures

Overall Survival from randomisation until 24 months

Overall trial start date

01/09/2012

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant 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 complete response (CR) as defined by Cheson criteria after treatment with conventional myelosuppressive chemotherapy e.g. anthracycline, araC, etoposide containing regimens
3. Patients are able to receive treatment as an outpatient
4. Adequate renal and hepatic function
5. Patients have given written informed consent
6. Eastern Cooperative Oncology Group (ECOG) performance status <=2
7. Male & Female; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 160; UK Sample Size: 160

Participant 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.
7. 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).
8. Previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 30 days before
9. Patients who have received prior treatment with demethylating agents such as 5azacitidine or decitabine
10. Patients with contraindications to receiving azacitidine or vorinostat such as hypersenstivity or patients unable to receive subcutaneous injection
11. Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis
12. Any co-morbidity that could limit compliance with the trial

Recruitment start date

01/09/2012

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Leukaemia and Lymphoma Research

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/11/2016: No publications found, verifying study status with principal investigator.