Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 550
- Locations
- 32
- Primary Endpoint
- Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
Detailed Description
OBJECTIVES:
- Determine the dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride in pediatric patients with acute lymphoblastic leukemia (ALL).
- Determine whether it is possible to reduce therapy in pediatric patients with low-risk ALL and a PVA (prednisolone-vincristine-asparaginase) score of 3+4 without loss of efficacy.
- Investigate the role of single nucleotide polymorphisms of infection defense gene for infectious complications during therapy in these patients.
- Reduce neurological complications by reducing doses of intrathecal methotrexate.
- Reduce allergic reactions against asparaginase (ASP) by using pegaspargase after E. coli ASP.
OUTLINE: This is a randomized, multicenter study.
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Prephase: Patients are randomized to 1 of 3 treatment arms.
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Arm I: Patients receive doxorubicin hydrochloride IV once.
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Arm II: Patients receive daunorubicin hydrochloride IV once.
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Arm III: Patients receive daunorubicin hydrochloride IV once at a higher dose than in arm II.
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Induction phase: All patients receive vincristine IV 4 times weekly, daunorubicin hydrochloride IV 3 times weekly, and oral prednisolone daily for 4 weeks.
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Intensive phase: Patients are stratified according to risk (low vs high).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 1 Year to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride
Reduce therapy in low-risk patients without loss of efficacy
Reduce neurological complications
Reduce allergic reactions against asparaginase
Secondary Outcomes
No secondary outcomes reported