Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults

Status: Recruiting
Location: See all (58) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Armenia
prof. R.O.Eolyan Hematology Center
COMPLETED
Yerevan
Belarus
Republican Research and Practical Center of Radiation Medicine and Human Ecology
RECRUITING
Homyel
Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology
RECRUITING
Minsk
Mogilev Regional Children's Hospital
RECRUITING
Mogilev
Kyrgyzstan
National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic
COMPLETED
Bishkek
Russian Federation
Arkhangelsk Regional Clinical Children's Hospital
RECRUITING
Arkhangelsk
Regional Clinical Children's Hospital
RECRUITING
Astrakhan
Altay Regional Clinical Children's Hospital
RECRUITING
Barnaul
Amur Regional Clinical Children's Hospital
RECRUITING
Blagoveshchensk
Bryansk Regional Children's Hospital
RECRUITING
Bryansk
Chelyabinsk Regional Clinical Children's Hospital
RECRUITING
Chelyabinsk
Transbaikal Regional Oncology Dispensary
RECRUITING
Chita
Irkutsk Regional Children Clinical Hospital
RECRUITING
Irkutsk
Ivanovo Regional Clinical Hospital
RECRUITING
Ivanovo
Republic Clinical Children's Hospital
RECRUITING
Izhevsk
Regional Clinical Children's Hospital
RECRUITING
Khabarovsk
Kirov Research Institute of Hematology and Blood Transfusion
RECRUITING
Kirov
Regional Clinical Children's Hospital
RECRUITING
Krasnodar
Krasnoyarsk Territorial Clinical Children's Hospital
RECRUITING
Krasnoyarsk
Kurgan Regional Clinical Children's Hospital
RECRUITING
Kurgan
Regional Clinical Children's Hospital
RECRUITING
Kursk
Regional Children's Hospital
RECRUITING
Lipetsk
Republic Children's Clinical Hospital
RECRUITING
Makhachkala
Morozov Children's Municipal Clinical Hospital
RECRUITING
Moscow
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev
RECRUITING
Moscow
Russian Children's Clinical Hospital
RECRUITING
Moscow
Murmansk Clinical Children's Hospital
RECRUITING
Murmansk
Republic Clinical Children's Hospital
RECRUITING
Nal'chik
Nizhnevartovsk Regional Clinical Children's Hospital
RECRUITING
Nizhnevartovsk
Regional Clinical Children's Hospital
RECRUITING
Nizhny Novgorod
Novokuznetsk Municipal Clinical Children's Hospital N4
RECRUITING
Novokuznetsk
Novosibirsk Central District Clinical Hospital
RECRUITING
Novosibirsk
Orenburg Regional Clinical Oncology Dispensary
RECRUITING
Orenburg
Regional Clinical Children's Hospital
RECRUITING
Oryol
Perm Territorial Clinical Children's Hospital
RECRUITING
Perm
Regional Clinical Children's Hospital
RECRUITING
Rostov-on-don
Rostov Research Institute of Oncology
RECRUITING
Rostov-on-don
N. Dmitrieva Ryazan Regional Clinical Children's Hospital
RECRUITING
Ryazan
Almazov National Medical Research Center
RECRUITING
Saint Petersburg
Children's Municipal Hospital N1
RECRUITING
Saint Petersburg
Municipal Clinical Hospital N31
RECRUITING
Saint Petersburg
N.N.Petrov National Medical Research Oncology Center
RECRUITING
Saint Petersburg
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University
RECRUITING
Saint Petersburg
Municipal Clinical Children's Hospital N1
RECRUITING
Samara
Regional Children's Clinical Hospital
RECRUITING
Stavropol
Surgut Regional Clinical Hospital
COMPLETED
Surgut
Republic Clinical Children's Hospital
RECRUITING
Syktyvkar
Tomsk Regional Clinical Hospital
RECRUITING
Tomsk
Tula Regional Clinical Children's Hospital
RECRUITING
Tula
Republic Clinical Children's Hospital
RECRUITING
Ulan-ude
Ulyanovsk Regional Children's Clinical Hospital
RECRUITING
Ulyanovsk
Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center
RECRUITING
Vladivostok
Vologda Regional Clinical Children's Hospital
RECRUITING
Vologda
Voronezh Regional Clinical Children's Hospital N1
RECRUITING
Voronezh
Republic Hospital N1 - National Medicine Centre
RECRUITING
Yakutsk
Regional Clinical Children's Hospital
RECRUITING
Yaroslavl
Regional Clinical Children's Hospital N1; Children Oncology and hematology Center
RECRUITING
Yekaterinburg
Uzbekistan
Research Institute of Hematology and Blood Transfusion
RECRUITING
Tashkent
Contact Information
Primary
Alexander I. Karachunskiy, Professor, MD
info@mbstudy.net
+7-926-218-84-09
Backup
Julia V. Roumiantseva, MD. PhD
j.roumiantseva@mbstudy.net
+7-903-730-39-78
Time Frame
Start Date: 2015-11
Estimated Completion Date: 2025-11
Participants
Target number of participants: 4000
Treatments
Experimental: Dexa intermittent
Induction therapy with intermittent Dexamethasone administration (1-15 days - 6 mg/m2, 15-22 day - pause, 22-29 days - 6 mg/m2).
Active_comparator: Dexa constant
Induction therapy with continuous Dexamethasone administration (6 mg/m2 1-29 days).
Active_comparator: Dexa
Therapy with Dexamethasone (6 mg/m2) as basic glucocorticoid preparation.
Experimental: Medrol
Therapy with Methylprednisolone (60 mg/m2) as basic glucocorticoid preparation.
Experimental: IDA
Induction and consolidation therapy with Idarubicin
Active_comparator: DNR
Induction and consolidation therapy with Daunorubicin
Experimental: Protocol Ib+
Two-phase induction therapy (additional second phase of induction - protocol Ib)
Active_comparator: Protocol Ib-
Standard induction therapy (without second phase)
Active_comparator: Bortezomib-
Consolidation therapy without Bortezomib
Experimental: Bortezomib+
Consolidation therapy with Bortezomib 1.3 mg/m2 N12 (N4 in each reinduction)
Sponsors
Leads: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

This content was sourced from clinicaltrials.gov