Childhood Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents
QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY
1. Whether the early PEG-asparaginase in induction will lead to the earlier achievement of
remission, improvement of days 8 and 15 responses leading to an earlier reconstitution
of bone marrow and immunocompetence, decrease of severe infections and early mortality
rate?
2. Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines
in standard risk group patients and to reduce treatment myelotoxicity?
3. Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18 doses
of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve treatment
outcome?
4. Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st
consolidation in intermediate risk patients will result in decrease of central nervous
system relapse incidence and improvement of event-free and overall survival? Whether the
increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation phase
(instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied with
enhanced toxicity?
5. Is it possible to completely avoid the cranial irradiation in intermediate risk
patients? In some subgroup of intermediate risk patients? Is it enough to control
neuroleukemia in these patients to introduce additional TIT in the consolidation phase
of treatment? How will change the possible late effects in these patients according to
the third arm of randomization?
6. Will the new risk group stratification to improve overall and event-free survival?
n/a
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