Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)

Last updated: February 4, 2020
Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT03390387
ALL-MB 2015
  • Ages 1-50
  • All Genders

Study 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 Criteria

Inclusion

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, andimmunological analysis of tumor cells in bone marrow (see "Diagnostics"). Patientswith B-cell (Burkitt) ALL are excluded.

  • Informed consent of the patient parents (guardians) to be treated in one of theclinics included in this multicenter study.

Exclusion

Exclusion Criteria:

  • ALL is a second malignancies;

  • The disease is a relapse of previously misdiagnosed and, therefore, inadequatelytreated 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 cytostatictherapy according to a specific chemotherapy protocol (differential diagnosis ofALL-AML (acute myeloid leukemia) is not possible, stratification according totherapeutic 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 sideeffects of treatment and/or complications of the disease

Study Design

Total Participants: 4000
Study Start date:
November 01, 2015
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • prof. R.O.Eolyan Hematology Center

    Ereván,
    Armenia

    Completed

  • Republican Research and Practical Center of Radiation Medicine and Human Ecology

    Gomel,
    Belarus

    Active - Recruiting

  • Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology

    Minsk,
    Belarus

    Active - Recruiting

  • Mogilev Regional Children's Hospital

    Mogilev,
    Belarus

    Active - Recruiting

  • National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic

    Bishkek,
    Kyrgyzstan

    Completed

  • Arkhangelsk Regional Clinical Children's Hospital

    Arkhangelsk,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Astrakhan,
    Russian Federation

    Active - Recruiting

  • Altay Regional Clinical Children's Hospital

    Barnaul,
    Russian Federation

    Active - Recruiting

  • Amur Regional Clinical Children's Hospital

    Blagoveshchensk,
    Russian Federation

    Active - Recruiting

  • Bryansk Regional Children's Hospital

    Bryansk,
    Russian Federation

    Active - Recruiting

  • Chelyabinsk Regional Clinical Children's Hospital

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • Transbaikal Regional Oncology Dispensary

    Chita,
    Russian Federation

    Active - Recruiting

  • Irkutsk Regional Children Clinical Hospital

    Irkutsk,
    Russian Federation

    Active - Recruiting

  • Ivanovo Regional Clinical Hospital

    Ivanovo,
    Russian Federation

    Active - Recruiting

  • Republic Clinical Children's Hospital

    Izhevsk,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Khabarovsk,
    Russian Federation

    Active - Recruiting

  • Kirov Research Institute of Hematology and Blood Transfusion

    Kirov,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Krasnodar,
    Russian Federation

    Active - Recruiting

  • Krasnoyarsk Territorial Clinical Children's Hospital

    Krasnoyarsk,
    Russian Federation

    Active - Recruiting

  • Kurgan Regional Clinical Children's Hospital

    Kurgan,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Kursk,
    Russian Federation

    Active - Recruiting

  • Regional Children's Hospital

    Lipetsk,
    Russian Federation

    Active - Recruiting

  • Republic Children's Clinical Hospital

    Makhachkala,
    Russian Federation

    Active - Recruiting

  • Morozov Children's Municipal Clinical Hospital

    Moscow,
    Russian Federation

    Active - Recruiting

  • Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev

    Moscow,
    Russian Federation

    Active - Recruiting

  • Russian Children's Clinical Hospital

    Moscow,
    Russian Federation

    Active - Recruiting

  • Murmansk Clinical Children's Hospital

    Murmansk,
    Russian Federation

    Active - Recruiting

  • Republic Clinical Children's Hospital

    Nal'chik,
    Russian Federation

    Active - Recruiting

  • Nizhnevartovsk Regional Clinical Children's Hospital

    Nizhnevartovsk,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Nizhny Novgorod,
    Russian Federation

    Active - Recruiting

  • Novokuznetsk Municipal Clinical Children's Hospital N4

    Novokuznetsk,
    Russian Federation

    Active - Recruiting

  • Novosibirsk Central District Clinical Hospital

    Novosibirsk,
    Russian Federation

    Active - Recruiting

  • Orenburg Regional Clinical Oncology Dispensary

    Orenburg,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Orël,
    Russian Federation

    Active - Recruiting

  • Perm Territorial Clinical Children's Hospital

    Perm,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Rostov-on-Don,
    Russian Federation

    Active - Recruiting

  • Rostov Research Institute of Oncology

    Rostov-on-Don,
    Russian Federation

    Active - Recruiting

  • N. Dmitrieva Ryazan Regional Clinical Children's Hospital

    Ryazan,
    Russian Federation

    Active - Recruiting

  • Almazov National Medical Research Center

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Children's Municipal Hospital N1

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Municipal Clinical Hospital N31

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • N.N.Petrov National Medical Research Oncology Center

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Municipal Clinical Children's Hospital N1

    Samara,
    Russian Federation

    Active - Recruiting

  • Regional Children's Clinical Hospital

    Stavropol,
    Russian Federation

    Active - Recruiting

  • Surgut Regional Clinical Hospital

    Surgut,
    Russian Federation

    Completed

  • Republic Clinical Children's Hospital

    Syktyvkar,
    Russian Federation

    Active - Recruiting

  • Tomsk Regional Clinical Hospital

    Tomsk,
    Russian Federation

    Active - Recruiting

  • Tula Regional Clinical Children's Hospital

    Tula,
    Russian Federation

    Active - Recruiting

  • Republic Clinical Children's Hospital

    Ulan-Ude,
    Russian Federation

    Active - Recruiting

  • Ulyanovsk Regional Children's Clinical Hospital

    Ulyanovsk,
    Russian Federation

    Active - Recruiting

  • Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center

    Vladivostok,
    Russian Federation

    Active - Recruiting

  • Vologda Regional Clinical Children's Hospital

    Vologda,
    Russian Federation

    Active - Recruiting

  • Voronezh Regional Clinical Children's Hospital N1

    Voronezh,
    Russian Federation

    Active - Recruiting

  • Republic Hospital N1 - National Medicine Centre

    Yakutsk,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital

    Yaroslavl,
    Russian Federation

    Active - Recruiting

  • Regional Clinical Children's Hospital N1; Children Oncology and hematology Center

    Yekaterinburg,
    Russian Federation

    Active - Recruiting

  • Research Institute of Hematology and Blood Transfusion

    Tashkent,
    Uzbekistan

    Active - Recruiting

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