ISRCTN ISRCTN88373119
DOI https://doi.org/10.1186/ISRCTN88373119
ClinicalTrials.gov number NCT00005863
Secondary identifying numbers G9800529
Submission date
25/10/2000
Registration date
25/10/2000
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

Dr DW Milligan
Scientific

Department of Haematology
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Phone +44 (0)121 424 3699
Email d.w.milligan@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific titleAcute Myeloid Leukaemia - High Risk (AML-HR)
Study acronymAML-HR
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLeukaemia
InterventionThree 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/11/1998
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants600
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/1998
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Haematology
Birmingham
B9 5SS
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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 15/06/2006 Yes No

Editorial Notes

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