Contact information
Type
Scientific
Primary contact
Prof AK Burnett
ORCID ID
Contact details
Department of Haematology
University of Wales College of Medicine
Heath Park
Cardiff
CF14 4XN
United Kingdom
+44 (0)29 2074 2375
burnettak@cardiff.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00005823
Protocol/serial number
LRF AML14
Study information
Scientific title
A randomised trial for patients with acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome aged 60 or over
Acronym
AML 14
Study hypothesis
As of 10/12/2009 this record was updated; all details can be found under the relevant section under the above update date.
Added as of 10/12/2009:
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy.
This randomised phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.
Ethics approval
The protocol was reviewed by the Clinical Trial Advisory Panel of the Leukaemia Research Fund and was approved by the Wales Multicentre Ethics Committee as well as each institution's ethical committee.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute myeloid leukaemia or high-risk myelodysplastic syndrome
Intervention
Patients will be randomised between intensive and non-intensive chemotherapy at diagnosis.
Those in the intensive treatment arm will be randomised between 50 mg/m^2/day daunorubicin versus 35 mg/m^2/day daunorubicin and 200 mg/m^2/day Ara-C versus 400 mg/m^2/day. Patients in the lower dose daunorubicin arm will be further randomised between PSC833 versus control, i.e., no PSC833. After three courses of treatment, patients in the intensive arm will be randomised between short (three courses) versus long (four courses) consolidation therapy.
Patients in the non-intensive arm will be randomised between hydroxyurea and low-dose Ara-C and 45 mg/m^2/day All-trans retinoic acid versus no retinoic acid.
Intervention type
Drug
Phase
Phase IV
Drug names
Daunorubicin
Primary outcome measures
Added as of 10/12/2009:
1. Survival
2. Response achievement
3. Response duration
Secondary outcome measures
Added as of 10/12/2009:
1. Toxicity by WHO Toxicity Grading after each treatment course
2. Quality of life EORTC QLQ-C30 at 3 days, 1 month, 3 months, and 6 months from study entry
3. Resource use (use of blood products, antibiotics and days in hospital) after each treatment course
Overall trial start date
01/12/1998
Overall trial end date
01/11/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Patients are eligible for AML 14 if:
1. They have one of the forms of acute myeloid leukaemia (this can be any type of the de novo or secondary AML, except acute promyelocytic leukaemia) or myelodysplastic syndrome (refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEB-t], chronic myelomonocytic leukemia [CMML]) with more than 10% myeloblasts in the bone marrow
2. They should normally be aged 60 or over, but patients under this age are eligible if the more intensive therapy employed in the current trial for younger patients with AML is not considered a suitable option
3. They have given informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
217 (added as of 02/01/2009)
Participant exclusion criteria
Added as of 10/12/2009:
1. Previously received cytotoxic chemotherapy for leukaemia
2. Acute promyelocytic leukaemia
3. In blast transformation of chronic myeloid leukaemia
4. Concurrent active malignancy
5. Patients with liver function test elevation greater than twice normal cannot receive Gemtuzumab Ozogamicin (Mylotarg) and are therefore not eligible for the non-intensive randomisation
Recruitment start date
01/12/1998
Recruitment end date
01/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Haematology
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Organisation
Leukaemia Research Fund (UK)
Sponsor details
43 Great Ormond Street
London
WC1N 3JJ
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Leukaemia Research Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17315155
Publication citations
-
Results
Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K, A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment., Cancer, 2007, 109, 6, 1114-1124, doi: 10.1002/cncr.22496.