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?
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
Republican Research and Practical Center of Radiation Medicine, Gomel, Belarus
Republic Research and Practical Center of Pediatric Oncology and Hematology, Minsk, Belarus
Mogilev Regional Children's Hospital, Mogilev, Belarus
Arkhangelsk Regional Children's Hospital, Arkhangelsk, Russian Federation
Regional Children's Hospital, Astrakhan, Russian Federation
Moscow Regional Cancer Dispensary, Balashikha, Russian Federation
Amur Regional Children's Hospital, Blagoveshchensk, Russian Federation
Chelyabinsk Regional Children's Clinical Hospital, Chelyabinsk, Russian Federation
Irkutsk Regional Children Clinical Hospital, Irkutsk, Russian Federation
Regional Clinical Hospital, Ivanovo, Russian Federation
Regional Children's Clinical Hospital, Khabarovsk, Russian Federation
Kirov Research Institute of Hematology and Blood Transfusion, Kirov, Russian Federation
Regional Children's Hospital, Krasnodar, Russian Federation
Krasnoyarsk Territorial Clinical Children Hospital, Krasnoyarsk, Russian Federation
Regional Children's Hospital, Kursk, Russian Federation
Republic Children's Clinical Hospital, Makhachkala, Russian Federation
Morozov Children's Clinical Hospital, Moscow, Russian Federation
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev, Moscow, Russian Federation
Russian Children's Clinic Hospital, Moscow, Russian Federation
Republic Children's Clinical Hospital, Nalchik, Russian Federation
District Children's Clinic Hospital, Nizhnevartovsk, Russian Federation
Regional Children's Clinic Hospital, Nizhny Novgorod, Russian Federation
Municipal Children's Clinic Hospital №4, Novokuznetsk, Russian Federation
Novosibirsk Central District Hospital, Novosibirsk, Russian Federation
Regional Clinical Oncology Dispensary, Orenburg, Russian Federation
Perm Regional Children's Clinic Hospital, Perm, Russian Federation
Regional Children's Hospital, Rostov-on-Don, Russian Federation
Rostov Research Institute of Oncology, Rostov-on-Don, Russian Federation
N. Dmitrieva Ryazan Regional Children's Hospital, Ryazan, Russian Federation
Children's Municipal Hospital №1, Saint Petersburg, Russian Federation
Municipal Hospital №31, Saint Petersburg, Russian Federation
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov State Medical University of Saint-Petersburg, Saint Petersburg, Russian Federation
Children's Municipal Clinical Hospital №1, Samara, Russian Federation
Profpathology and Hematology Clinic; Saratov State Medical University, Saratov, Russian Federation
Regional Children's Clinical Hospital, Stavropol, Russian Federation
Surgut Central District Clinical Hospital, Surgut, Russian Federation
Tomsk Regional Clinical Hospital, Tomsk, Russian Federation
Tula Regional Children's Hospital, Tula, Russian Federation
Republic Children's Clinical Hospital, Ulan-Ude, Russian Federation
Ulyanovsk Regional Children's Clinical Hospital, Ulyanovsk, Russian Federation
Municipal Children's City Hospital, Territorial Children's Hematological Center, Vladivostok, Russian Federation
Voronezh Regional Children Clinical Hospital №1, Voronezh, Russian Federation
Republic Hospital №1 - National Medicine Centre, Yakutsk, Russian Federation
Regional Children's Clinical Hospital, Yaroslavl, Russian Federation
Regional Children's Clinical Hospital № 1, Yekaterinburg, Russian Federation
Research Institute of Hematology and Blood Transfusion, Tashkent, Uzbekistan