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Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS (RAvVA)

Primary Purpose

Leukemia, Myeloid, Acute

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Azacitidine
Vorinostat
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Adults with AML (except Acute Promyelocytic Leukaemia (APL)) as defined by the World Health Organisation (WHO) Classification or patients with high risk MDS categorised as INT-2 or high risk according to the International Prognostic Scoring System (IPSS) who are deemed ineligible for intensive chemotherapy on the grounds of age or co-morbidities with ONE of the following disease status:- i) Newly diagnosed OR

ii) Relapsed Disease: patients must have achieved a previous morphological CR and show evidence of recurrent disease OR

iii) Refractory Disease: patients who have failed to achieve a morphological CR with previous therapy

  • Patients are able to receive treatment as out-patient
  • Adequate renal and hepatic function as defined in the Protocol
  • Patients have given written informed consent
  • ECOG performance status less than or equal to 2

Exclusion Criteria:

  • Patients with greater than class III NYHA cardiac impairment
  • Blastic transformation of Chronic Myeloid Leukaemia
  • Prior allogeneic/autologous haematopoietic stem cell transplant
  • Pregnant or lactating women
  • Adults of reproductive potential not willing to use appropriate, effective, contraception during the trial and for specified amount of time afterwards
  • Patients who have received prior histone deacetylase inhibitor (HDACi) 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)
  • 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. (Patients receiving anti-tumour therapies to control blood counts may enrol into the trial)
  • Patients who have received prior treatment with demethylating agents such as 5-azacitidine or decitabine
  • Patients with contraindications to receiving azacitidine or vorinostat such as hypersensitivity, patients unable to have a subcutaneous injection or swallow oral capsules
  • Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis
  • Any co-morbidity that could limit compliance with the trial

Sites / Locations

  • Barts and the London NHS Trust
  • King's College Hospital
  • Hammersmith Hospital
  • The Christie Hospital
  • Royal Liverpool University Hospital
  • Belfast City Hospital
  • Nottingham University Hospitals NHS Trust
  • Oxford University Hospitals NHS Trust
  • University Hospital of Wales
  • Queen Elizabeth Hospital
  • St James's University Hospital
  • Beatson West of Scotland Cancer Centre
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

azacitidine

azacitidine and vorinostat

Arm Description

azacitidine (75mg/m2) by SC injection on 7 consecutive days (excluding weekends), starting day 1 of 28-day cycles for up to 6 cycles. This should be delivered in a 5-2-2 schedule

Patients will receive (75mg/m2) azacitidine by SC injection on 7 consecutive days (excluding weekends), starting day 1 of 28-day cycles for up to 6 cycles. Azacitidine should be delivered in a 5-2-2 schedule. Vorinostat (300mg bid) will be taken orally for 7 consecutive days starting on day 3 of each cycle in 28-day cycles for up to 6 cycles. (Day 3 is defined as the 3rd day of azacitidine administration).

Outcomes

Primary Outcome Measures

Phase II - Overall Response Rate
Patients are expected to receive 6 cycles of treatment which is expected to be completed over a period of 6 months. Each cycle lasts for 28 days. Overall response rate (CR, CRi, PR) as defined by Cheson criteria will be assessed during this time. This will be measured for all patients receiving treatment recruited over a 24 month period.
Phase II - Overall Survival
Overall survival is defined as the time from date of randomisation to the date of death from any cause. Patients discontinuing study, lost to follow up or still alive at the end of the study (up to 24 months) will be censored at the date of last follow-up.

Secondary Outcome Measures

Phase II - Toxicities measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Toxicities will be measured and graded according to the NCI CTCAE v4 from the date of randomisation until 28 days following treatment discontinuation over the duration of the follow up period which is 24 months.
Phase II - Complete Remission (CR) within 6 cycles of treatment
Complete remission within 6 cycles of treatment as defined by Cheson criteria will be assessed. It is expected patients will receive 6 cycles of treatment, which is expected to be completed over a period of 6 months, as each cycle is 28 days. This will be measured for all patients receiving treatment recruited over a 24 month period.
Phase II - Duration of response
This will be measured from date of documented response until date of documented progression, assessed for up to 24 months.
Phase II - Dose intensity
Dose intensity defined as the total dose prescribed to each patient as a proportion of the protocol dose. This will measured for each patient receiving treatment, assessed up to 24 months.
Phase II - Quality of Life measured by questionnaires
Quality of Life will be measured using the EORTC QLQ-C30 and EuroQol EQ-5D-5L questionnaires. This will be measured for each patient receiving treatment until end of treatment, assessed for up to 24 months.
Phase II - Medical Resource Use
Medical resource use is defined in terms of days in hospital, blood product usage and days on anti-biotics and will be measured from date of randomisation until 24 months.

Full Information

First Posted
June 6, 2012
Last Updated
April 30, 2021
Sponsor
University of Birmingham
Collaborators
Leukemia Research Fund, Celgene, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01617226
Brief Title
Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS
Acronym
RAvVA
Official Title
Phase II Randomised Trial of 5-azacitidine Versus 5-azacitidine in Combination With Vorinostat in Patients With Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes Ineligible for Intensive Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Birmingham
Collaborators
Leukemia Research Fund, Celgene, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicentre, open-label, randomised phase II trial comparing azacitidine monotherapy with combined azacitidine and vorinostat in patients with newly diagnosed, relapsed or refractory acute myeloid leukaemia or high risk myelodysplastic syndromes ineligible for intensive chemotherapy.
Detailed Description
Acute Myeloid Leukaemia (AML) is a common haematological malignancy. As a result of improvements in myelosuppressive chemotherapy and stem cell transplantation, the outcome of children and young adults with AML has improved substantially in the past three decades. By contrast there has only been limited progress in the development of new treatments for older adults in whom long term survival is less than 20% at present. There is an urgent need to develop more effective treatment options for the treatment of AML and high risk MDS in older adults. Accumulating evidence suggests that Azacitidine is a potentially important treatment modality in newly diagnosed, relapsed/refractory AML and high risk MDS. Phase II trials in AML and MDS demonstrate increased clinical activity of azacitidine when combined with a HDACi. However no randomised trials have yet examined the important question of whether concurrent HDACi administration increases the clinical activity of Azacitidine. Vorinostat is a new HDACi which shows significant clinical activity in combination with Azacitidine in patients with AML and MDS. We therefore propose a randomised trial of azacitidine compared with azacitidine and vorinostat combination therapy in older adults with newly diagnosed, relapsed, refractory AML or high risk MDS ineligible for intensive chemotherapy. This will represent the first randomised trial, addressing whether there is a clinical benefit to be gained from combining treatment with azacitidine with a HDACi in patients with newly diagnosed, relapsed, refractory AML or high risk MDS for whom limited therapeutic options currently exist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
azacitidine
Arm Type
Active Comparator
Arm Description
azacitidine (75mg/m2) by SC injection on 7 consecutive days (excluding weekends), starting day 1 of 28-day cycles for up to 6 cycles. This should be delivered in a 5-2-2 schedule
Arm Title
azacitidine and vorinostat
Arm Type
Active Comparator
Arm Description
Patients will receive (75mg/m2) azacitidine by SC injection on 7 consecutive days (excluding weekends), starting day 1 of 28-day cycles for up to 6 cycles. Azacitidine should be delivered in a 5-2-2 schedule. Vorinostat (300mg bid) will be taken orally for 7 consecutive days starting on day 3 of each cycle in 28-day cycles for up to 6 cycles. (Day 3 is defined as the 3rd day of azacitidine administration).
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
vidaza, ATC code L01BC07, cas number 320-67-2
Intervention Description
Azacitidine both arms; 75mg/m^2 by subcutaneous injection for 7 days of a 28-day cycle for up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Vorinostat
Other Intervention Name(s)
MK-0683, ATC code L01XX38, cas number 149647-78-9
Intervention Description
Vorinostat (with azacitidine) combined therapy arm; 300mg twice daily for 7 days starting on day 3 of each cycle in 28-day cycles for up to 6 cycles.
Primary Outcome Measure Information:
Title
Phase II - Overall Response Rate
Description
Patients are expected to receive 6 cycles of treatment which is expected to be completed over a period of 6 months. Each cycle lasts for 28 days. Overall response rate (CR, CRi, PR) as defined by Cheson criteria will be assessed during this time. This will be measured for all patients receiving treatment recruited over a 24 month period.
Time Frame
Upto 6 months
Title
Phase II - Overall Survival
Description
Overall survival is defined as the time from date of randomisation to the date of death from any cause. Patients discontinuing study, lost to follow up or still alive at the end of the study (up to 24 months) will be censored at the date of last follow-up.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Phase II - Toxicities measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Description
Toxicities will be measured and graded according to the NCI CTCAE v4 from the date of randomisation until 28 days following treatment discontinuation over the duration of the follow up period which is 24 months.
Time Frame
Up to 28 days
Title
Phase II - Complete Remission (CR) within 6 cycles of treatment
Description
Complete remission within 6 cycles of treatment as defined by Cheson criteria will be assessed. It is expected patients will receive 6 cycles of treatment, which is expected to be completed over a period of 6 months, as each cycle is 28 days. This will be measured for all patients receiving treatment recruited over a 24 month period.
Time Frame
Up to 6 months
Title
Phase II - Duration of response
Description
This will be measured from date of documented response until date of documented progression, assessed for up to 24 months.
Time Frame
Up to 24 months
Title
Phase II - Dose intensity
Description
Dose intensity defined as the total dose prescribed to each patient as a proportion of the protocol dose. This will measured for each patient receiving treatment, assessed up to 24 months.
Time Frame
Up to 24 months
Title
Phase II - Quality of Life measured by questionnaires
Description
Quality of Life will be measured using the EORTC QLQ-C30 and EuroQol EQ-5D-5L questionnaires. This will be measured for each patient receiving treatment until end of treatment, assessed for up to 24 months.
Time Frame
Up to 24 months
Title
Phase II - Medical Resource Use
Description
Medical resource use is defined in terms of days in hospital, blood product usage and days on anti-biotics and will be measured from date of randomisation until 24 months.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Adults with AML (except Acute Promyelocytic Leukaemia (APL)) as defined by the World Health Organisation (WHO) Classification or patients with high risk MDS categorised as INT-2 or high risk according to the International Prognostic Scoring System (IPSS) who are deemed ineligible for intensive chemotherapy on the grounds of age or co-morbidities with ONE of the following disease status:- i) Newly diagnosed OR ii) Relapsed Disease: patients must have achieved a previous morphological CR and show evidence of recurrent disease OR iii) Refractory Disease: patients who have failed to achieve a morphological CR with previous therapy Patients are able to receive treatment as out-patient Adequate renal and hepatic function as defined in the Protocol Patients have given written informed consent ECOG performance status less than or equal to 2 Exclusion Criteria: Patients with greater than class III NYHA cardiac impairment Blastic transformation of Chronic Myeloid Leukaemia Prior allogeneic/autologous haematopoietic stem cell transplant Pregnant or lactating women Adults of reproductive potential not willing to use appropriate, effective, contraception during the trial and for specified amount of time afterwards Patients who have received prior histone deacetylase inhibitor (HDACi) 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) 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. (Patients receiving anti-tumour therapies to control blood counts may enrol into the trial) Patients who have received prior treatment with demethylating agents such as 5-azacitidine or decitabine Patients with contraindications to receiving azacitidine or vorinostat such as hypersensitivity, patients unable to have a subcutaneous injection or swallow oral capsules Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis Any co-morbidity that could limit compliance with the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles F Craddock, Professor
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts and the London NHS Trust
City
London
State/Province
Greater London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
The Christie Hospital
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AD
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG27 2UH
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
South Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B152TH
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

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Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS

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