Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
12/09/2007
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

Dr DW Milligan

ORCID ID

Contact details

Department of Haematology
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
+44 (0)121 424 3699
d.w.milligan@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00005863

Protocol/serial number

G9800529

Study information

Scientific title

Acronym

AML-HR

Study hypothesis

To improve the outcome of patients with high risk AML by randomised evaluation of:
1. The standard ADE (Ara-C,daunorubicin, etoposide) reinduction regimen versus the newer FLA (fludarabine, high-dose Ara-C) regimen
2. The addition of growth factor (G-CSF) during and after chemotherapy.
3. The addition of retinoic acid (ATRA) during and after chemotherapy. Patients may be entered into all three randomisations, any combination of two randomisations, or just one randomisation. The therapeutic relevance of morphology, genetics and other features will also be investigated.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Leukaemia

Intervention

Three randomised comparisons:
1. ADE versus FLA
2. Granulocyte Colony Stimulating Factor (G-CSF) versus control
3. All-trans-retinoic acid (ATRA) versus control

Follow-up until death.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Survival
2. Complete remission (CR) rates and reason for failure
3. Duration of remission
4. Toxicity
5. Quality of life
5. Supportive care requirements

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/1998

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. High risk acute myeloid leukaemia (AML) (de novo or secondary, except acute promyelocytic leukemia [APL])
2. Suitable for intensive therapy
3. Informed consent given. High risk AML is defined as:
(a) Resistant disease (greater than 15% blasts in bone marrow) after one induction course
(b) Refractory disease (ie not in complete remission [CR]) after two or more induction courses
(c) Relapse from first CR (with more than 5% blasts in bone marrow)
(d) In complete or partial remission after one induction course but with adverse cytogenic abnormalities at diagnosis

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. APL
2. Concurrent active malignancy
3. Blast transformation of CML
4. Relapse from second or greater CR
5. Severe renal impairment (creatinine clearance less than 30 millilitres per minute)
6. Pregnant, lactating or potentially fertile and not taking adequate contraceptive precautions

Recruitment start date

01/11/1998

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Haematology
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16484584

Publication citations

  1. Results

    Milligan DW, Wheatley K, Littlewood T, Craig JI, Burnett AK, , Fludarabine and cytosine are less effective than standard ADE chemotherapy in high-risk acute myeloid leukemia, and addition of G-CSF and ATRA are not beneficial: results of the MRC AML-HR randomized trial., Blood, 2006, 107, 12, 4614-4622, doi: 10.1182/blood-2005-10-4202.

Additional files

Editorial Notes