| DEC-NET Serial number FR349 |
 See also: GB455 |
| Published online | 03/02/2005 15.15.00 |
| Last updated | 08/09/2005 10.38.06 |
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| Other protocol ID number | EU -20063 |
| Current trial status | Closed to recruitment of participants: follow-up continuing |
Major Disease
(ICD9 class) | LYMPHOID LEUKEMIA ACUTE |
| Experimental drug |
Prednisone
Treatment regimen (dosage and duration)
Induction Phase : 60 mg/m2/day 3 times daily PO or IV from day 1 to day 7.
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Dexamethasone
Treatment regimen (dosage and duration)
Induction Phase :6 mg/m2/day in 3 divided doses PO or IV from day 8 to day 28. After day 28 it is tapered off over 1 week with cessation at day 35.
OCTADD : 6 mg/m2/day in 3 divided doses PO from day 1 to day 14. Progressive dose reduction and cessation at day 21.
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vincristine
Treatment regimen (dosage and duration)
1.5 mg/m2/day IVD at days 1 - 8 - 15 -22 and 29.
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daunorubicin
Treatment regimen (dosage and duration)
Induction phase:30 mg/m2 as IV infusion over 60mn at days 1 -8 - 15 - 22. |
Cytarabine
Treatment regimen (dosage and duration)
Induction phase : 75 mg/m2/day as IV infusion over 30 mn during 14 days (days 8 to 21).
MARAM : 3 g/m2/12h as IV infusion over 3h at days 15 -16 and days 22 - 23
OCTADD |
L-Asparaginase
Treatment regimen (dosage and duration)
Induction phase:5000 U/m2/day is given either IV as a 1-hour infusion or IM at days 15 - 18 - 22 - 25 - 29 and 33.
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6-mercaptopurine
Treatment regimen (dosage and duration)
MARAM : 25 mg/m2/day PO during 14 days (d1-d14)
OCTADD : 60 mg/m2/day during 28 days (d1-d28).
VIMARAM : 25 mg/m2/day during 14 days (d1-d14). |
methotrexate
Treatment regimen (dosage and duration)
MARAM : 5000 mg/m2 as a 24 hour IV infusion at days 1 and 8 |
6-thioguanine
Treatment regimen (dosage and duration)
OCTADD (Part 2) : 60 mg/m2/day PO days 36 to 49 |
cyclophosphamide
Treatment regimen (dosage and duration)
500 mg/m2/day as IV infusion over 1 hur at days 36 and 43 |
Etoposide (VP16)
Treatment regimen (dosage and duration)
maintenance phase : 120 mg/m2/day IV during 2 hours at day 1 from weeks 8 and 9 (2 injections).
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| Gender | Both |
| Age (range) | < 1 year |
Eligibility criteria |
| Inclusion criteria |
| - Patients aged 365 days or less at the time of diagnosis of ALL.
Central nervous system or testicular localisation at diagnosis and patients with trisomy 21 are ellgible.
- ALL confirmed by cytochemistry and immunophenotyping
- No previous chemotherapy or irradiation
- Informed written consent of parent/legal guardian |
| Exclusion criteria |
| Not spécified |
Trial design/methodology |
| Phase | 3 |
| Kind of study | Efficacy
Safety
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| Design | Randomised
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| Purpose of study |
| Principal :
- To compare the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic leukemia and acute myeloid leukemia .
- To evaluate the interest of complementary consolidation chemotherapy (VIMARAM), placed between the late intensification chemotherapy and the beginning of the maintenance regimen in no allograft children.
Secondary objectives:
- To determine the prognostic value of age, immunophenotype, MLL gene rearrangement in patients treated with these regimens
- To evaluate the toxicity of this intensive protocol.
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| Summary of study design, objectives, and ongoing research findings |
| The protocol consists of cures of intensive chemotherapy to treat ALL patients younger than one year.
The various steps are as follows:
1/Initial corticotherapy
2/Induction phase : to obtain complete remission
3/Consolidation phases (MARAM, OCTADD and VIMARAM). VIMARAM cure is given to half of the patients, after randomization, in order to evaluate the interet of adding a third cure 4/Maintenance therapy
Duration of treatment is approximately 2 years.
The objectives are :
- To improve recovery rates
- To limit bone marrow transplantation to children not very sensitive to treatments.
- To reduce the frequency of side effects. |
