Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)
NCT ID: NCT03390387
Last Updated: 2020-02-05
Study Results
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Basic Information
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RECRUITING
NA
4000 participants
INTERVENTIONAL
2015-11-30
2025-11-30
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dexa intermittent
Induction therapy with intermittent Dexamethasone administration (1-15 days - 6 mg/m2, 15-22 day - pause, 22-29 days - 6 mg/m2).
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.
Dexa constant
Induction therapy with continuous Dexamethasone administration (6 mg/m2 1-29 days).
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.
Dexa
Therapy with Dexamethasone (6 mg/m2) as basic glucocorticoid preparation.
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.
Medrol
Therapy with Methylprednisolone (60 mg/m2) as basic glucocorticoid preparation.
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.
IDA
Induction and consolidation therapy with Idarubicin
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).
DNR
Induction and consolidation therapy with Daunorubicin
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).
Protocol Ib+
Two-phase induction therapy (additional second phase of induction - protocol Ib)
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)
Protocol Ib-
Standard induction therapy (without second phase)
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)
Bortezomib-
Consolidation therapy without Bortezomib
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)
Bortezomib+
Consolidation therapy with Bortezomib 1.3 mg/m2 N12 (N4 in each reinduction)
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).
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* The start of induction therapy within a time interval of study recruitment phase.
* The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow (see "Diagnostics"). Patients with B-cell (Burkitt) ALL are excluded.
* Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this multicenter study.
Exclusion Criteria
* The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;
* There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
* There is a lack of important data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol (differential diagnosis of ALL-AML (acute myeloid leukemia) is not possible, stratification according to therapeutic group is not possible);
* The patient was treated before for a long time with cytotoxic drugs;
* There were treatment deviations not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
1 Year
50 Years
ALL
No
Sponsors
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Federal Research Institute of Pediatric Hematology, Oncology and Immunology
OTHER
Responsible Party
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Karachunskiy Alexander
Deputy director - Director of Institute of Oncology, Radiology and Nuclear Medicine of Federal Research Institute of Pediatric hematology, Oncology and Immunology
Principal Investigators
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Alexander I. Karachunskiy, Professor, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute of Pediatric Hematology, Oncology and Immunology
Locations
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prof. R.O.Eolyan Hematology Center
Yerevan, , Armenia
Republican Research and Practical Center of Radiation Medicine and Human Ecology
Homyel, , 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, , Russia
Regional Clinical Children's Hospital
Astrakhan, , Russia
Altay Regional Clinical Children's Hospital
Barnaul, , Russia
Amur Regional Clinical Children's Hospital
Blagoveshchensk, , Russia
Bryansk Regional Children's Hospital
Bryansk, , Russia
Chelyabinsk Regional Clinical Children's Hospital
Chelyabinsk, , Russia
Transbaikal Regional Oncology Dispensary
Chita, , Russia
Irkutsk Regional Children Clinical Hospital
Irkutsk, , Russia
Ivanovo Regional Clinical Hospital
Ivanovo, , Russia
Republic Clinical Children's Hospital
Izhevsk, , Russia
Regional Clinical Children's Hospital
Khabarovsk, , Russia
Kirov Research Institute of Hematology and Blood Transfusion
Kirov, , Russia
Regional Clinical Children's Hospital
Krasnodar, , Russia
Krasnoyarsk Territorial Clinical Children's Hospital
Krasnoyarsk, , Russia
Kurgan Regional Clinical Children's Hospital
Kurgan, , Russia
Regional Clinical Children's Hospital
Kursk, , Russia
Regional Children's Hospital
Lipetsk, , Russia
Republic Children's Clinical Hospital
Makhachkala, , Russia
Morozov Children's Municipal Clinical Hospital
Moscow, , Russia
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev
Moscow, , Russia
Russian Children's Clinical Hospital
Moscow, , Russia
Murmansk Clinical Children's Hospital
Murmansk, , Russia
Republic Clinical Children's Hospital
Nal'chik, , Russia
Nizhnevartovsk Regional Clinical Children's Hospital
Nizhnevartovsk, , Russia
Regional Clinical Children's Hospital
Nizhny Novgorod, , Russia
Novokuznetsk Municipal Clinical Children's Hospital N4
Novokuznetsk, , Russia
Novosibirsk Central District Clinical Hospital
Novosibirsk, , Russia
Orenburg Regional Clinical Oncology Dispensary
Orenburg, , Russia
Regional Clinical Children's Hospital
Oryol, , Russia
Perm Territorial Clinical Children's Hospital
Perm, , Russia
Regional Clinical Children's Hospital
Rostov-on-Don, , Russia
Rostov Research Institute of Oncology
Rostov-on-Don, , Russia
N. Dmitrieva Ryazan Regional Clinical Children's Hospital
Ryazan, , Russia
Almazov National Medical Research Center
Saint Petersburg, , Russia
Children's Municipal Hospital N1
Saint Petersburg, , Russia
Municipal Clinical Hospital N31
Saint Petersburg, , Russia
N.N.Petrov National Medical Research Oncology Center
Saint Petersburg, , Russia
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University
Saint Petersburg, , Russia
Municipal Clinical Children's Hospital N1
Samara, , Russia
Regional Children's Clinical Hospital
Stavropol, , Russia
Surgut Regional Clinical Hospital
Surgut, , Russia
Republic Clinical Children's Hospital
Syktyvkar, , Russia
Tomsk Regional Clinical Hospital
Tomsk, , Russia
Tula Regional Clinical Children's Hospital
Tula, , Russia
Republic Clinical Children's Hospital
Ulan-Ude, , Russia
Ulyanovsk Regional Children's Clinical Hospital
Ulyanovsk, , Russia
Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center
Vladivostok, , Russia
Vologda Regional Clinical Children's Hospital
Vologda, , Russia
Voronezh Regional Clinical Children's Hospital N1
Voronezh, , Russia
Republic Hospital N1 - National Medicine Centre
Yakutsk, , Russia
Regional Clinical Children's Hospital
Yaroslavl, , Russia
Regional Clinical Children's Hospital N1; Children Oncology and hematology Center
Yekaterinburg, , Russia
Research Institute of Hematology and Blood Transfusion
Tashkent, , Uzbekistan
Countries
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Central Contacts
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Related Links
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Study web-site
Other Identifiers
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ALL-MB 2015
Identifier Type: -
Identifier Source: org_study_id
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