Intensive compared with nonintensive chemotherapy in treating older patients with acute myeloid leukaemia or myelodysplastic syndrome

ISRCTN	ISRCTN62207270
DOI	https://doi.org/10.1186/ISRCTN62207270
ClinicalTrials.gov number	NCT00005823
Secondary identifying numbers	LRF AML14

Submission date: 01/07/2001
Registration date: 01/07/2001
Last edited: 17/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof AK Burnett
Scientific

Department of Haematology
University of Wales College of Medicine
Heath Park
Cardiff
CF14 4XN
United Kingdom

Phone	+44 (0)29 2074 2375
Email	burnettak@cardiff.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised trial for patients with acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome aged 60 or over
Study acronym	AML 14
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Daunorubicin
Primary outcome measure	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 study start date	01/12/1998
Completion date	01/11/2003

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target number of participants	217 (added as of 02/01/2009)
Key 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
Key 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
Date of first enrolment	01/12/1998
Date of final enrolment	01/11/2003

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Department of Haematology

Cardiff
CF14 4XN
United Kingdom

Sponsor information

Leukaemia Research Fund (UK)
Charity

43 Great Ormond Street
London
WC1N 3JJ
United Kingdom

Website	http://dspace.dial.pipex.com/lrf-//
"ROR"	https://ror.org/0055acf80

Funders

Funder type

Charity

Leukaemia Research Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	15/03/2007		Yes	No

Editorial Notes

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)