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
Scientific
Department of Haematology
University of Wales College of Medicine
Heath Park
Cardiff
CF14 4XN
United Kingdom
| Phone | +44 (0)29 2074 2375 |
|---|---|
| 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 | Both |
| 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
CF14 4XN
United Kingdom
Sponsor information
Leukaemia Research Fund (UK)
Charity
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)
