Clinical trial NCT03390387: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Acute Lymphoblastic Leukemia
Keywords: Acute lymphoblastic leukemia, children, adolescents, treatment
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 4000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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

Primary outcomes:
measure: Event-free survival
timeFrame: 3 years, 5 years and 10 years after study start
measure: Overall survival
timeFrame: 3 years, 5 years and 10 years after study start
measure: Cumulative incidence of relapse
timeFrame: 3 years, 5 years and 10 years after study start
Secondary outcomes:
measure: Early death rate
timeFrame: 3 years, 5 years and 10 years after study start
measure: Remission death rate
timeFrame: 3 years, 5 years and 10 years after study start
Other outcomes:
Locations:
city: Ereván
country: Armenia
facility: prof. R.O.Eolyan Hematology Center
city: Gomel
country: Belarus
facility: Republican Research and Practical Center of Radiation Medicine and Human Ecology
city: Minsk
country: Belarus
facility: Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology
city: Mogilev
country: Belarus
facility: Mogilev Regional Children's Hospital
city: Bishkek
country: Kyrgyzstan
facility: National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Children's Hospital
city: Astrakhan
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Barnaul
country: Russian Federation
facility: Altay Regional Clinical Children's Hospital
city: Blagoveshchensk
country: Russian Federation
facility: Amur Regional Clinical Children's Hospital
city: Bryansk
country: Russian Federation
facility: Bryansk Regional Children's Hospital
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Children's Hospital
city: Chita
country: Russian Federation
facility: Transbaikal Regional Oncology Dispensary
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Children Clinical Hospital
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Clinical Hospital
city: Izhevsk
country: Russian Federation
facility: Republic Clinical Children's Hospital
city: Khabarovsk
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Kirov
country: Russian Federation
facility: Kirov Research Institute of Hematology and Blood Transfusion
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Territorial Clinical Children's Hospital
city: Kurgan
country: Russian Federation
facility: Kurgan Regional Clinical Children's Hospital
city: Kursk
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Lipetsk
country: Russian Federation
facility: Regional Children's Hospital
city: Makhachkala
country: Russian Federation
facility: Republic Children's Clinical Hospital
city: Moscow
country: Russian Federation
facility: Morozov Children's Municipal Clinical Hospital
city: Moscow
country: Russian Federation
facility: Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev
city: Moscow
country: Russian Federation
facility: Russian Children's Clinical Hospital
city: Murmansk
country: Russian Federation
facility: Murmansk Clinical Children's Hospital
city: Nal'chik
country: Russian Federation
facility: Republic Clinical Children's Hospital
city: Nizhnevartovsk
country: Russian Federation
facility: Nizhnevartovsk Regional Clinical Children's Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Novokuznetsk
country: Russian Federation
facility: Novokuznetsk Municipal Clinical Children's Hospital N4
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Central District Clinical Hospital
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Oncology Dispensary
city: Orël
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Perm
country: Russian Federation
facility: Perm Territorial Clinical Children's Hospital
city: Rostov-on-Don
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Research Institute of Oncology
city: Ryazan
country: Russian Federation
facility: N. Dmitrieva Ryazan Regional Clinical Children's Hospital
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Center
city: Saint Petersburg
country: Russian Federation
facility: Children's Municipal Hospital N1
city: Saint Petersburg
country: Russian Federation
facility: Municipal Clinical Hospital N31
city: Saint Petersburg
country: Russian Federation
facility: N.N.Petrov National Medical Research Oncology Center
city: Saint Petersburg
country: Russian Federation
facility: R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University
city: Samara
country: Russian Federation
facility: Municipal Clinical Children's Hospital N1
city: Stavropol
country: Russian Federation
facility: Regional Children's Clinical Hospital
city: Surgut
country: Russian Federation
facility: Surgut Regional Clinical Hospital
city: Syktyvkar
country: Russian Federation
facility: Republic Clinical Children's Hospital
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Children's Hospital
city: Ulan-Ude
country: Russian Federation
facility: Republic Clinical Children's Hospital
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Children's Clinical Hospital
city: Vladivostok
country: Russian Federation
facility: Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center
city: Vologda
country: Russian Federation
facility: Vologda Regional Clinical Children's Hospital
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Children's Hospital N1
city: Yakutsk
country: Russian Federation
facility: Republic Hospital N1 - National Medicine Centre
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Children's Hospital
city: Yekaterinburg
country: Russian Federation
facility: Regional Clinical Children's Hospital N1; Children Oncology and hematology Center
city: Tashkent
country: Uzbekistan
facility: Research Institute of Hematology and Blood Transfusion
Study officials:
affiliation: Research Institute of Pediatric Hematology, Oncology and Immunology
name: Alexander I. Karachunskiy, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: