Acute Myeloid Leukaemia - High Risk (AML-HR)
ISRCTN | ISRCTN88373119 |
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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
Scientific
Department of Haematology
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Phone | +44 (0)121 424 3699 |
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d.w.milligan@bham.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Not Specified |
Scientific title | Acute Myeloid Leukaemia - High Risk (AML-HR) |
Study acronym | AML-HR |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/11/1998 |
Completion date | 31/12/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 600 |
Key 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 |
Key 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 |
Date of first enrolment | 01/11/1998 |
Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Haematology
Birmingham
B9 5SS
United Kingdom
B9 5SS
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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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
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 | |
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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 | 15/06/2006 | Yes | No |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)