| Source of record | UK Co-ordinating Committee on Cancer Research (UKCCCR) |
| ISRCTN | ISRCTN64649191 |
| Serial number at source | MRC AML12CH |
| Title of trial | Medical Research Council Twelfth Acute Myeloid Leukaemia Trial (Children): AML 12 CH |
| Disease or condition | Leukaemia (acute) |
| Current status of trial | Open |
| Objectives | 1. To compare two induction schedules with respect to achievement and duration of remission, survival, toxicity and supportive care requirements.
2. To compare four versus five courses of treatment [where the final course is either chemotherapy or bone marrow transplant (BMT)] with respect to remission duration, relapse rates, deaths in remission and overall survival.
3. To compare the value of allogenic bone marrow transplantation (allo-BMT) versus conventional chemotherapy with respect to remission duration, relapse rates, deaths in remission and overall survival.
4. To reduce toxicity without compromising survival by restricting the number of patients receiving BMT. |
| Design/methodology | Two randomisationsNB. Trial is linked to MRC AML12 (Adults). Target accrual includes both children and adults |
| Eligibility criteria | 1. Patients have one of the forms of acute myeloid leukaemia this can be any type of de novo or secondary acute myeloid leukaemia
2. Suitable for intensive chemotherapy
3. Under the age of 16 years
4. No previous cytotoxic chemotherapy for leukaemia
5. No concurrent malignancy |
| Sample size | Current accrual: 436 |
| Randomised interventions | INDUCTION CHEMOTHERAPY - FIRST RANDOMISATION
Patients are randomised to one of two induction regimens:
1. ADE Regimen:
Two courses of chemotherapy with cytarabine, daunorubicin and etoposide (ADE). ADE 10+3+5 (course 1) followed by ADE 8+3+5 (course 2)
2. MAE Regimen:
Two courses of chemotherapy with mitozantrone, cytarabine and etoposide (MAE). MAE 3+10+5 (course 1) followed by MAE 3+8+5 (course 2)
POST-INDUCTION CHEMOTHERAPY
Patients who have completed both courses of induction chemotherapy and are in complete remission receive one course of consolidation chemotherapy with amsacrine, cytarabine and etoposide (MACE)
INTRATHECAL CHEMOTHERAPY
Children without CNS disease at diagnosis receive three courses of triple intrathecal chemotherapy with methotrexate, cytarabine and hydrocortisone. A course of triple intrathecal chemotherapy to be given after each of the first three courses of chemotherapy.
Children with CNS disease at diagnosis receive two courses of triple intrathecal chemotherapy each week for a minimum of six courses. This intensive phase is followed by monthly courses of triple intrathecal chemotherapy until after the final course of systemic chemotherapy has been given.
CONSOLIDATION CHEMOTHERAPY - SECOND RANDOMISATION
Patients with a matching sibling donor and who are not good risk are randomised to either:
1. Regimen A:
Allogenic bone marrow transplantation (allo-BMT)
2. Regimen B:
A single course of chemotherapy with cytarabine and asparaginase (CLASP) followed by allo-BMT
Patients without a matched sibling donor or who are good risk are randomised to either:
1. Regimen C:
A single course of chemotherapy with mitozantrone and cytarabine (MidAC)
2. Regimen D:
A course of CLASP followed by MidAC |
| Sponsor | Medical Research Council |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
LONDON NW1 2DA
Tel: +44 (0) 20 7670 4723
Fax: +44 (0) 20 7670 4818
|
| Further information | Further information about this trial may be obtained from UKCCCR Register's own website, which contains full trial reports. |
| General information | Please visit the UKCCCR Register website for further general information. |
| Date live in mRCT | 01 April 2007 |
