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Spots Global Cancer Trial Database for Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Alexander I. Karachunskiy, Professor, MD

Affiliation: Research Institute of Pediatric Hematology, Oncology and Immunology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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