4,000
Participants
Start Date
November 30, 2015
Primary Completion Date
November 30, 2020
Study Completion Date
November 30, 2025
Dexamethasone continuous
6 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 3 mg/m2, days 32-34 - 1.5 mg/m2, days 35-36 - 0.75 mg/m2; then dexamethasone is discontinued completely.
Dexamethasone intermittent
6 mg/m2, per os, in two divided doses per day q12 hours. Days: 1-14 (dose in the first few days is depending on the total tumor mass) and 22-28; days 15-21 - pause. From day 29 the dose of dexamethasone is reducing: days 29-30 - 3 mg/m2, days 31-32 - 1.5 mg/m2, then dexamethasone is discontinued completely.
Dexamethasone
"Induction: 6 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 3 mg/m2, days 32-34 - 1.5 mg/m2, days 35-36 - 0.75 mg/m2; then dexamethasone is discontinued completely.~Consolidation: 6 mg/m2 per os, in two divided doses per day q12 hours. Weeks 13-14 (days 85-98), weeks 21-22 (days 141-154), weeks 29-30 (days 197-210), weeks 37-38 (days 253-260), weeks 45-46 (days 309-316), weeks 53-54 (days 365-372).~Maintenance therapy: 6 mg/m2, per os, in two divided doses per day q12 hours, for 10 days followed by quick discontinuation during 3 days. Weeks 61-62, 69-70, 77-78, 85-86, 93-94."
Methylprednisolone
"Induction: 60 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 30 mg/m2, days 32-34 - 15 mg/m2, days 35-36 - 8 mg/m2; then methylprednisolone is discontinued completely.~Consolidation: 60 mg/m2 per os, in two divided doses per day q12 hours. Weeks 13-14 (days 85-98), weeks 21-22 (days 141-154), weeks 29-30 (days 197-210), weeks 37-38 (days 253-260), weeks 45-46 (days 309-316), weeks 53-54 (days 365-372).~Maintenance therapy: 60 mg/m2, per os, in two divided doses per day q12 hours, for 10 days followed by quick discontinuation during 3 days. Weeks 61-62, 69-70, 77-78, 85-86, 93-94."
Daunorubicin
Induction: 45 mg/m2, intravenously, for 6 hours on days 8 and 22. Consolidation: 30 mg/m2, intravenously, for 6 hours on days 44, 65 (consolidation S1); 107, 121 (consolidation S2); and 163 (consolidation S3).
Idarubicin
Induction: 10 mg/m2, intravenously, for 6 hours on days 8 and 22. Consolidation: 8 mg/m2, intravenously, for 6 hours on days 44, 65 (consolidation S1); 107, 121 (consolidation S2); and 163 (consolidation S3).
Bortezomib
1.3 mg/м2, intravenously, bolus injection. Days 85, 89, 92, 96 (consolidation S1); 141, 145, 148, 152 (consolidation S2) and 197, 201, 204, 208 (consolidation S3).
Second phase of induction
Cyclophosphamide (1,000 mg/m2, intravenously, for 1 hour - days 43 and 71); Cytarabine (75 mg/m2/day, intravenously, bolus injection. Four blocks of 4 days each, days 46-48, 52-55, 59-62, and 66-69); 6-mercaptopurine (60 mg/m2/day, per os, days 43-71); Triple intrathecal therapy (days 52 and 66)
Standard induction therapy
Dexamethasone (6 mg/m2, p/o; 1-29 days); Daunorubicin (45 mg/m2, i.v.; day 8 and 22); Vincristine (1.5 mg/m2, i.v.; days 8, 15, 22, 29 and 36); Triple intrathecal therapy (Methotrexate/Cytarabine/Prednisone; days 0/1, 8, 15, 22, 29 and 36)
Standard consolidation therapy
Consolidation consists of 3 phases: S1, S2 and S3. Each phase is a 6-week therapy with 6-mercaptopurine (50 mg/m2 per day, daily, orally), methotrexate (30 мг/м2, i.m., weekly) and L-asparaginase (10 000 U/m2, i.m., weekly), followed by 2 weeks of re-induction with Vincristine (1.5 mg/m2, i.v., days 1 and 8 of reinduction) plus Dexamethasone (6 mg/m2, p/o, daily, for 10 days followed by quick discontinuation during 3 days). Daunorubicin (30 mg/м2, i.v., N2 during S1, N2 during S2 and N1 during S3). Triple intrathecal therapy (Methotrexate/Cytarabine/Prednisone) N12 (4 injections per each phase)
COMPLETED
prof. R.O.Eolyan Hematology Center, Yerevan
RECRUITING
Republican Research and Practical Center of Radiation Medicine and Human Ecology, Homyel
RECRUITING
Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology, Minsk
RECRUITING
Mogilev Regional Children's Hospital, Mogilev
COMPLETED
National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic, Bishkek
RECRUITING
Arkhangelsk Regional Clinical Children's Hospital, Arkhangelsk
RECRUITING
Regional Clinical Children's Hospital, Astrakhan
RECRUITING
Altay Regional Clinical Children's Hospital, Barnaul
RECRUITING
Amur Regional Clinical Children's Hospital, Blagoveshchensk
RECRUITING
Bryansk Regional Children's Hospital, Bryansk
RECRUITING
Chelyabinsk Regional Clinical Children's Hospital, Chelyabinsk
RECRUITING
Transbaikal Regional Oncology Dispensary, Chita
RECRUITING
Irkutsk Regional Children Clinical Hospital, Irkutsk
RECRUITING
Ivanovo Regional Clinical Hospital, Ivanovo
RECRUITING
Republic Clinical Children's Hospital, Izhevsk
RECRUITING
Regional Clinical Children's Hospital, Khabarovsk
RECRUITING
Kirov Research Institute of Hematology and Blood Transfusion, Kirov
RECRUITING
Regional Clinical Children's Hospital, Krasnodar
RECRUITING
Krasnoyarsk Territorial Clinical Children's Hospital, Krasnoyarsk
RECRUITING
Kurgan Regional Clinical Children's Hospital, Kurgan
RECRUITING
Regional Clinical Children's Hospital, Kursk
RECRUITING
Regional Children's Hospital, Lipetsk
RECRUITING
Republic Children's Clinical Hospital, Makhachkala
RECRUITING
Morozov Children's Municipal Clinical Hospital, Moscow
RECRUITING
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev, Moscow
RECRUITING
Russian Children's Clinical Hospital, Moscow
RECRUITING
Murmansk Clinical Children's Hospital, Murmansk
RECRUITING
Republic Clinical Children's Hospital, Nal'chik
RECRUITING
Nizhnevartovsk Regional Clinical Children's Hospital, Nizhnevartovsk
RECRUITING
Regional Clinical Children's Hospital, Nizhny Novgorod
RECRUITING
Novokuznetsk Municipal Clinical Children's Hospital N4, Novokuznetsk
RECRUITING
Novosibirsk Central District Clinical Hospital, Novosibirsk
RECRUITING
Orenburg Regional Clinical Oncology Dispensary, Orenburg
RECRUITING
Regional Clinical Children's Hospital, Oryol
RECRUITING
Perm Territorial Clinical Children's Hospital, Perm
RECRUITING
Regional Clinical Children's Hospital, Rostov-on-Don
RECRUITING
Rostov Research Institute of Oncology, Rostov-on-Don
RECRUITING
N. Dmitrieva Ryazan Regional Clinical Children's Hospital, Ryazan
RECRUITING
Almazov National Medical Research Center, Saint Petersburg
RECRUITING
Children's Municipal Hospital N1, Saint Petersburg
RECRUITING
Municipal Clinical Hospital N31, Saint Petersburg
RECRUITING
N.N.Petrov National Medical Research Oncology Center, Saint Petersburg
RECRUITING
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University, Saint Petersburg
RECRUITING
Municipal Clinical Children's Hospital N1, Samara
RECRUITING
Regional Children's Clinical Hospital, Stavropol
COMPLETED
Surgut Regional Clinical Hospital, Surgut
RECRUITING
Republic Clinical Children's Hospital, Syktyvkar
RECRUITING
Tomsk Regional Clinical Hospital, Tomsk
RECRUITING
Tula Regional Clinical Children's Hospital, Tula
RECRUITING
Republic Clinical Children's Hospital, Ulan-Ude
RECRUITING
Ulyanovsk Regional Children's Clinical Hospital, Ulyanovsk
RECRUITING
Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center, Vladivostok
RECRUITING
Vologda Regional Clinical Children's Hospital, Vologda
RECRUITING
Voronezh Regional Clinical Children's Hospital N1, Voronezh
RECRUITING
Republic Hospital N1 - National Medicine Centre, Yakutsk
RECRUITING
Regional Clinical Children's Hospital, Yaroslavl
RECRUITING
Regional Clinical Children's Hospital N1; Children Oncology and hematology Center, Yekaterinburg
RECRUITING
Research Institute of Hematology and Blood Transfusion, Tashkent
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
OTHER