| DEC-NET Serial number FR339 |
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| Published online | 06/12/2004 15.00.00 |
| Last updated | 23/11/2006 12.18.07 |
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| Other protocol ID number | EORTC-58951 |
| Current trial status | Open (actively recruiting new participants) |
Major Disease
(ICD9 class) | Lymphoid leukemia |
| Experimental drug |
Dexamethasone
Treatment regimen (dosage and duration)
Prephase (day 1 to day 7) : 3 mg/m² every 12 hours (i.e. 6 mg/m² total daily dose)orally or intravenously
Protocole 1A (VLR-AR-VHR)(days 8 to 28): 6 mg/m² orally |
prednisolone
Treatment regimen (dosage and duration)
Prephase : prednisolone p.o. (or methyl-prednisolone i.v.) 30 mg/m² every 12 hours (i.e.
60 mg/m² total daily dose)
Protocol IA (VLR AR VHR): PDN 60 mg/m² p.o. for 21 days (8 to 28)
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L-Asparaginase
Treatment regimen (dosage and duration)
Dose : 10 000 U/m2 per injection
Arm S (Short): no asparaginase during phase Ib and 4 injections of asparaginase during phase IIA
or
Arm L (Long) : 8 injections of asparaginase during phase Ib and 8 during phase IIA
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| Gender | Both |
| Age (range) | From birth to 18 years |
Eligibility criteria |
| Inclusion criteria |
| 1. Elligibility for registration
- Histologically confirmed acute lymphoblastic leukemia (ALL) of FAB L1 or L2 morphology whaterver the immunophenotype
- Histologically confirmed precursor B or precursor T lymphoblastic non-Hodgkin's lymphoma (NHL)
Patients are classified in risk groups: Very low-risk (VLR), Average risk (AR) and Very high risk (VHR) patients.
2. Elligibility for the first randomisation at day 1 of the prephase
Previuos criteria (elligibility for registration)
Informed consent
3. Elligibility for the second randomisation
Timing: at completion of protocol IA
For ALL patients:
- achievement of complete remission or good partial response (GPR) between day 28 and day 42 of protocol I.
- absence of VHR features
- absence of severe toxicity possibly related to A.ase
For NHL patients
- either complete response or GPR between day 28 and day 42 of protocol I
- absence of severe toxicity possibly related to A.ase
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| Exclusion criteria |
| 1. Acute lymphoblastic leukemia of FAB L3 morphology.
2. No diffuse large cell B-cell lymphoma, Burkitt's lymphoma, or high-grade B-cell lymphoma (Burkitt-like). |
Trial design/methodology |
| Phase | 3 |
| Kind of study | Efficacy
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| Design | Randomised
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| Purpose of study |
| 1/To assess the value of dexamethasone (DM) vs prednisolone (PRDL) administered during induction therapy, in terms of event-free and overall survival, in children with acute lymphoblastic leukemia (ALL) or lymphoblastic non-Hodgkin's lymphoma (LNHL).
2/ To assess the value of increasing the number of administrations of asparaginase during consolidation and late intensification therapy, in terms of disease-free and overall survival, in children without very high-risk (VHR) features.
3/ To compare the response rate in children treated with prephase therapy comprising DM vs PRDL and intrathecal methotrexate.
4/ To compare the incidence and grade of toxic effects of these treatment regimens in these children.
5/ To compare the long-term effects of these treatment regimens on growth and pubertal development, neurocognitive, cardiac, and endocrine function, and incidence of aseptic bone necrosis in these children.
6/ To evaluate the proportion of children with VHR disease when defined according to extended VHR criteria, and assess the prognostic importance of the new VHR features (cytogenetics and minimal-residual disease).
7/ To compare the feasibility of the VHR chemotherapy protocol in patients treated with DM vs PRDL. |
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| Summary of study design, objectives, and ongoing research findings |
| This multicenter study is undertaken in patients with acute lymphoblastic leukemia and non Hodgkin lymphoblastic lymphoma in order to compare:
1. Dexamethasone versus prednisone during induction therapy (Days 1 to 7).
Patients are randomized into:
Arm I:prednisolone orally or methylprednisolone intravenously.
Arm II: dexamethasone orally or intravenously
2. Prolonged versus conventional asparaginase treatment during consolidation and late intensification therapy
Patients are also randomized into :
Arm I: no asparaginase followed by short-term asparaginase intravenously or intramuscularly (4 administrations between days 8 and 18).
Arm II: asparaginasee intravenously or intramuscularly (8 administratiuons between days 38 and 62)followed by long-term asparaginase intravenously or intramusularly (8 administrations between days 8 and 32).
The value of prednisolone versus dexamethasone and the value of increasing the number of asparaginase administrations will be evaluated by the rate of event free survival and overall survival.
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