Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015) (ALL-MB 2015)
Childhood Acute Lymphoblastic Leukemia
About this trial
This is an interventional treatment trial for Childhood Acute Lymphoblastic Leukemia focused on measuring Acute lymphoblastic leukemia, children, adolescents, treatment
Eligibility Criteria
Inclusion Criteria:
- Age at diagnosis at 1 to 50 years.
- 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:
- ALL is a second malignancies;
- 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
Sites / Locations
- prof. R.O.Eolyan Hematology Center
- Republican Research and Practical Center of Radiation Medicine and Human EcologyRecruiting
- Republic Research and Practical Center of Pediatric Oncology, Hematology and ImmunologyRecruiting
- Mogilev Regional Children's HospitalRecruiting
- National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic
- Arkhangelsk Regional Clinical Children's HospitalRecruiting
- Regional Clinical Children's HospitalRecruiting
- Altay Regional Clinical Children's HospitalRecruiting
- Amur Regional Clinical Children's HospitalRecruiting
- Bryansk Regional Children's HospitalRecruiting
- Chelyabinsk Regional Clinical Children's HospitalRecruiting
- Transbaikal Regional Oncology DispensaryRecruiting
- Irkutsk Regional Children Clinical HospitalRecruiting
- Ivanovo Regional Clinical HospitalRecruiting
- Republic Clinical Children's HospitalRecruiting
- Regional Clinical Children's HospitalRecruiting
- Kirov Research Institute of Hematology and Blood TransfusionRecruiting
- Regional Clinical Children's HospitalRecruiting
- Krasnoyarsk Territorial Clinical Children's HospitalRecruiting
- Kurgan Regional Clinical Children's HospitalRecruiting
- Regional Clinical Children's HospitalRecruiting
- Regional Children's HospitalRecruiting
- Republic Children's Clinical HospitalRecruiting
- Morozov Children's Municipal Clinical HospitalRecruiting
- Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry RogachevRecruiting
- Russian Children's Clinical HospitalRecruiting
- Murmansk Clinical Children's HospitalRecruiting
- Republic Clinical Children's HospitalRecruiting
- Nizhnevartovsk Regional Clinical Children's HospitalRecruiting
- Regional Clinical Children's HospitalRecruiting
- Novokuznetsk Municipal Clinical Children's Hospital N4Recruiting
- Novosibirsk Central District Clinical HospitalRecruiting
- Orenburg Regional Clinical Oncology DispensaryRecruiting
- Regional Clinical Children's HospitalRecruiting
- Perm Territorial Clinical Children's HospitalRecruiting
- Regional Clinical Children's HospitalRecruiting
- Rostov Research Institute of OncologyRecruiting
- N. Dmitrieva Ryazan Regional Clinical Children's HospitalRecruiting
- Almazov National Medical Research CenterRecruiting
- Children's Municipal Hospital N1Recruiting
- Municipal Clinical Hospital N31Recruiting
- N.N.Petrov National Medical Research Oncology CenterRecruiting
- R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical UniversityRecruiting
- Municipal Clinical Children's Hospital N1Recruiting
- Regional Children's Clinical HospitalRecruiting
- Surgut Regional Clinical Hospital
- Republic Clinical Children's HospitalRecruiting
- Tomsk Regional Clinical HospitalRecruiting
- Tula Regional Clinical Children's HospitalRecruiting
- Republic Clinical Children's HospitalRecruiting
- Ulyanovsk Regional Children's Clinical HospitalRecruiting
- Regional Children's Clinical Hospital N1, Territorial Children's Hematological CenterRecruiting
- Vologda Regional Clinical Children's HospitalRecruiting
- Voronezh Regional Clinical Children's Hospital N1Recruiting
- Republic Hospital N1 - National Medicine CentreRecruiting
- Regional Clinical Children's HospitalRecruiting
- Regional Clinical Children's Hospital N1; Children Oncology and hematology CenterRecruiting
- Research Institute of Hematology and Blood TransfusionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Active Comparator
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Active Comparator
Experimental
Dexa intermittent
Dexa constant
Dexa
Medrol
IDA
DNR
Protocol Ib+
Protocol Ib-
Bortezomib-
Bortezomib+
Induction therapy with intermittent Dexamethasone administration (1-15 days - 6 mg/m2, 15-22 day - pause, 22-29 days - 6 mg/m2).
Induction therapy with continuous Dexamethasone administration (6 mg/m2 1-29 days).
Therapy with Dexamethasone (6 mg/m2) as basic glucocorticoid preparation.
Therapy with Methylprednisolone (60 mg/m2) as basic glucocorticoid preparation.
Induction and consolidation therapy with Idarubicin
Induction and consolidation therapy with Daunorubicin
Two-phase induction therapy (additional second phase of induction - protocol Ib)
Standard induction therapy (without second phase)
Consolidation therapy without Bortezomib
Consolidation therapy with Bortezomib 1.3 mg/m2 N12 (N4 in each reinduction)