Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
10/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://dspace.dial.pipex.com/lrf-//

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

  1. 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.

Additional files

Editorial Notes