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Brief Title: Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)
Official Title: Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
Study ID: NCT03390387
Brief Summary: QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY 1. Will the new risk group stratification (especially of T-ALL) to improve overall and event-free survival? 2. Will the new protocol is effective and feasible in patients older than 15 years, and especially in young adults? 3. Whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy? 4. Whether the methylprednisolone administration as basic glucocorticoids during induction, consolidation and maintenance therapy will lead to decrease of severe infections and early mortality rate, improve survival and therapy compliance in adolescents and young adults with B-precursor ALL? 5. Whether the administration of Bortezomib in patients with B-precursor ALL with initial WBC≥100,000/µl will improve treatment outcome? 6. Whether the administration of Idarubicin instead Daunorubicin in low-risk T-ALL patients and two-phase induction in intermediate-risk T-ALL patients will reduce relapse rate and improve survival?
Detailed Description:
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
prof. R.O.Eolyan Hematology Center, Ereván, , Armenia
Republican Research and Practical Center of Radiation Medicine and Human Ecology, Gomel, , Belarus
Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology, Minsk, , Belarus
Mogilev Regional Children's Hospital, Mogilev, , Belarus
National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic, Bishkek, , Kyrgyzstan
Arkhangelsk Regional Clinical Children's Hospital, Arkhangelsk, , Russian Federation
Regional Clinical Children's Hospital, Astrakhan, , Russian Federation
Altay Regional Clinical Children's Hospital, Barnaul, , Russian Federation
Amur Regional Clinical Children's Hospital, Blagoveshchensk, , Russian Federation
Bryansk Regional Children's Hospital, Bryansk, , Russian Federation
Chelyabinsk Regional Clinical Children's Hospital, Chelyabinsk, , Russian Federation
Transbaikal Regional Oncology Dispensary, Chita, , Russian Federation
Irkutsk Regional Children Clinical Hospital, Irkutsk, , Russian Federation
Ivanovo Regional Clinical Hospital, Ivanovo, , Russian Federation
Republic Clinical Children's Hospital, Izhevsk, , Russian Federation
Regional Clinical Children's Hospital, Khabarovsk, , Russian Federation
Kirov Research Institute of Hematology and Blood Transfusion, Kirov, , Russian Federation
Regional Clinical Children's Hospital, Krasnodar, , Russian Federation
Krasnoyarsk Territorial Clinical Children's Hospital, Krasnoyarsk, , Russian Federation
Kurgan Regional Clinical Children's Hospital, Kurgan, , Russian Federation
Regional Clinical Children's Hospital, Kursk, , Russian Federation
Regional Children's Hospital, Lipetsk, , Russian Federation
Republic Children's Clinical Hospital, Makhachkala, , Russian Federation
Morozov Children's Municipal Clinical Hospital, Moscow, , Russian Federation
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev, Moscow, , Russian Federation
Russian Children's Clinical Hospital, Moscow, , Russian Federation
Murmansk Clinical Children's Hospital, Murmansk, , Russian Federation
Republic Clinical Children's Hospital, Nal'chik, , Russian Federation
Nizhnevartovsk Regional Clinical Children's Hospital, Nizhnevartovsk, , Russian Federation
Regional Clinical Children's Hospital, Nizhny Novgorod, , Russian Federation
Novokuznetsk Municipal Clinical Children's Hospital N4, Novokuznetsk, , Russian Federation
Novosibirsk Central District Clinical Hospital, Novosibirsk, , Russian Federation
Orenburg Regional Clinical Oncology Dispensary, Orenburg, , Russian Federation
Regional Clinical Children's Hospital, Orël, , Russian Federation
Perm Territorial Clinical Children's Hospital, Perm, , Russian Federation
Regional Clinical Children's Hospital, Rostov-on-Don, , Russian Federation
Rostov Research Institute of Oncology, Rostov-on-Don, , Russian Federation
N. Dmitrieva Ryazan Regional Clinical Children's Hospital, Ryazan, , Russian Federation
Almazov National Medical Research Center, Saint Petersburg, , Russian Federation
Children's Municipal Hospital N1, Saint Petersburg, , Russian Federation
Municipal Clinical Hospital N31, Saint Petersburg, , Russian Federation
N.N.Petrov National Medical Research Oncology Center, Saint Petersburg, , Russian Federation
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University, Saint Petersburg, , Russian Federation
Municipal Clinical Children's Hospital N1, Samara, , Russian Federation
Regional Children's Clinical Hospital, Stavropol, , Russian Federation
Surgut Regional Clinical Hospital, Surgut, , Russian Federation
Republic Clinical Children's Hospital, Syktyvkar, , Russian Federation
Tomsk Regional Clinical Hospital, Tomsk, , Russian Federation
Tula Regional Clinical Children's Hospital, Tula, , Russian Federation
Republic Clinical Children's Hospital, Ulan-Ude, , Russian Federation
Ulyanovsk Regional Children's Clinical Hospital, Ulyanovsk, , Russian Federation
Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center, Vladivostok, , Russian Federation
Vologda Regional Clinical Children's Hospital, Vologda, , Russian Federation
Voronezh Regional Clinical Children's Hospital N1, Voronezh, , Russian Federation
Republic Hospital N1 - National Medicine Centre, Yakutsk, , Russian Federation
Regional Clinical Children's Hospital, Yaroslavl, , Russian Federation
Regional Clinical Children's Hospital N1; Children Oncology and hematology Center, Yekaterinburg, , Russian Federation
Research Institute of Hematology and Blood Transfusion, Tashkent, , Uzbekistan
Name: Alexander I. Karachunskiy, Professor, MD
Affiliation: Research Institute of Pediatric Hematology, Oncology and Immunology
Role: PRINCIPAL_INVESTIGATOR