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

Primary Purpose

Childhood Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dexamethasone continuous
Dexamethasone intermittent
Dexamethasone
Methylprednisolone
Daunorubicin
Idarubicin
Bortezomib
Second phase of induction
Standard induction therapy
Standard consolidation therapy
Sponsored by
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1 Year - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Dexa intermittent

Dexa constant

Dexa

Medrol

IDA

DNR

Protocol Ib+

Protocol Ib-

Bortezomib-

Bortezomib+

Arm Description

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)

Outcomes

Primary Outcome Measures

Event-free survival
Overall survival
Cumulative incidence of relapse

Secondary Outcome Measures

Early death rate
Remission death rate

Full Information

First Posted
December 27, 2017
Last Updated
February 4, 2020
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT03390387
Brief Title
Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)
Acronym
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY Will the new risk group stratification (especially of T-ALL) to improve overall and event-free survival? Will the new protocol is effective and feasible in patients older than 15 years, and especially in young adults? Whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy? 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? Whether the administration of Bortezomib in patients with B-precursor ALL with initial WBC≥100,000/µl will improve treatment outcome? 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Acute Lymphoblastic Leukemia
Keywords
Acute lymphoblastic leukemia, children, adolescents, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexa intermittent
Arm Type
Experimental
Arm Description
Induction therapy with intermittent Dexamethasone administration (1-15 days - 6 mg/m2, 15-22 day - pause, 22-29 days - 6 mg/m2).
Arm Title
Dexa constant
Arm Type
Active Comparator
Arm Description
Induction therapy with continuous Dexamethasone administration (6 mg/m2 1-29 days).
Arm Title
Dexa
Arm Type
Active Comparator
Arm Description
Therapy with Dexamethasone (6 mg/m2) as basic glucocorticoid preparation.
Arm Title
Medrol
Arm Type
Experimental
Arm Description
Therapy with Methylprednisolone (60 mg/m2) as basic glucocorticoid preparation.
Arm Title
IDA
Arm Type
Experimental
Arm Description
Induction and consolidation therapy with Idarubicin
Arm Title
DNR
Arm Type
Active Comparator
Arm Description
Induction and consolidation therapy with Daunorubicin
Arm Title
Protocol Ib+
Arm Type
Experimental
Arm Description
Two-phase induction therapy (additional second phase of induction - protocol Ib)
Arm Title
Protocol Ib-
Arm Type
Active Comparator
Arm Description
Standard induction therapy (without second phase)
Arm Title
Bortezomib-
Arm Type
Active Comparator
Arm Description
Consolidation therapy without Bortezomib
Arm Title
Bortezomib+
Arm Type
Experimental
Arm Description
Consolidation therapy with Bortezomib 1.3 mg/m2 N12 (N4 in each reinduction)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone continuous
Intervention Description
6 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 3 mg/m2, days 32-34 - 1.5 mg/m2, days 35-36 - 0.75 mg/m2; then dexamethasone is discontinued completely.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intermittent
Intervention Description
6 mg/m2, per os, in two divided doses per day q12 hours. Days: 1-14 (dose in the first few days is depending on the total tumor mass) and 22-28; days 15-21 - pause. From day 29 the dose of dexamethasone is reducing: days 29-30 - 3 mg/m2, days 31-32 - 1.5 mg/m2, then dexamethasone is discontinued completely.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Induction: 6 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 3 mg/m2, days 32-34 - 1.5 mg/m2, days 35-36 - 0.75 mg/m2; then dexamethasone is discontinued completely. Consolidation: 6 mg/m2 per os, in two divided doses per day q12 hours. Weeks 13-14 (days 85-98), weeks 21-22 (days 141-154), weeks 29-30 (days 197-210), weeks 37-38 (days 253-260), weeks 45-46 (days 309-316), weeks 53-54 (days 365-372). Maintenance therapy: 6 mg/m2, per os, in two divided doses per day q12 hours, for 10 days followed by quick discontinuation during 3 days. Weeks 61-62, 69-70, 77-78, 85-86, 93-94.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Induction: 60 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 30 mg/m2, days 32-34 - 15 mg/m2, days 35-36 - 8 mg/m2; then methylprednisolone is discontinued completely. Consolidation: 60 mg/m2 per os, in two divided doses per day q12 hours. Weeks 13-14 (days 85-98), weeks 21-22 (days 141-154), weeks 29-30 (days 197-210), weeks 37-38 (days 253-260), weeks 45-46 (days 309-316), weeks 53-54 (days 365-372). Maintenance therapy: 60 mg/m2, per os, in two divided doses per day q12 hours, for 10 days followed by quick discontinuation during 3 days. Weeks 61-62, 69-70, 77-78, 85-86, 93-94.
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Description
Induction: 45 mg/m2, intravenously, for 6 hours on days 8 and 22. Consolidation: 30 mg/m2, intravenously, for 6 hours on days 44, 65 (consolidation S1); 107, 121 (consolidation S2); and 163 (consolidation S3).
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Description
Induction: 10 mg/m2, intravenously, for 6 hours on days 8 and 22. Consolidation: 8 mg/m2, intravenously, for 6 hours on days 44, 65 (consolidation S1); 107, 121 (consolidation S2); and 163 (consolidation S3).
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
1.3 mg/м2, intravenously, bolus injection. Days 85, 89, 92, 96 (consolidation S1); 141, 145, 148, 152 (consolidation S2) and 197, 201, 204, 208 (consolidation S3).
Intervention Type
Drug
Intervention Name(s)
Second phase of induction
Intervention Description
Cyclophosphamide (1,000 mg/m2, intravenously, for 1 hour - days 43 and 71); Cytarabine (75 mg/m2/day, intravenously, bolus injection. Four blocks of 4 days each, days 46-48, 52-55, 59-62, and 66-69); 6-mercaptopurine (60 mg/m2/day, per os, days 43-71); Triple intrathecal therapy (days 52 and 66)
Intervention Type
Drug
Intervention Name(s)
Standard induction therapy
Intervention Description
Dexamethasone (6 mg/m2, p/o; 1-29 days); Daunorubicin (45 mg/m2, i.v.; day 8 and 22); Vincristine (1.5 mg/m2, i.v.; days 8, 15, 22, 29 and 36); Triple intrathecal therapy (Methotrexate/Cytarabine/Prednisone; days 0/1, 8, 15, 22, 29 and 36)
Intervention Type
Drug
Intervention Name(s)
Standard consolidation therapy
Intervention Description
Consolidation consists of 3 phases: S1, S2 and S3. Each phase is a 6-week therapy with 6-mercaptopurine (50 mg/m2 per day, daily, orally), methotrexate (30 мг/м2, i.m., weekly) and L-asparaginase (10 000 U/m2, i.m., weekly), followed by 2 weeks of re-induction with Vincristine (1.5 mg/m2, i.v., days 1 and 8 of reinduction) plus Dexamethasone (6 mg/m2, p/o, daily, for 10 days followed by quick discontinuation during 3 days). Daunorubicin (30 mg/м2, i.v., N2 during S1, N2 during S2 and N1 during S3). Triple intrathecal therapy (Methotrexate/Cytarabine/Prednisone) N12 (4 injections per each phase)
Primary Outcome Measure Information:
Title
Event-free survival
Time Frame
3 years, 5 years and 10 years after study start
Title
Overall survival
Time Frame
3 years, 5 years and 10 years after study start
Title
Cumulative incidence of relapse
Time Frame
3 years, 5 years and 10 years after study start
Secondary Outcome Measure Information:
Title
Early death rate
Time Frame
3 years, 5 years and 10 years after study start
Title
Remission death rate
Time Frame
3 years, 5 years and 10 years after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander I. Karachunskiy, Professor, MD
Phone
+7-926-218-84-09
Email
info@mbstudy.net
First Name & Middle Initial & Last Name or Official Title & Degree
Julia V. Roumiantseva, MD. PhD
Phone
+7-903-730-39-78
Email
j.roumiantseva@mbstudy.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander I. Karachunskiy, Professor, MD
Organizational Affiliation
Research Institute of Pediatric Hematology, Oncology and Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
prof. R.O.Eolyan Hematology Center
City
Ereván
Country
Armenia
Individual Site Status
Completed
Facility Name
Republican Research and Practical Center of Radiation Medicine and Human Ecology
City
Gomel
Country
Belarus
Individual Site Status
Recruiting
Facility Name
Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology
City
Minsk
Country
Belarus
Individual Site Status
Recruiting
Facility Name
Mogilev Regional Children's Hospital
City
Mogilev
Country
Belarus
Individual Site Status
Recruiting
Facility Name
National Oncology and Hematology Center, Ministry of Health of the Kyrgyz Republic
City
Bishkek
Country
Kyrgyzstan
Individual Site Status
Completed
Facility Name
Arkhangelsk Regional Clinical Children's Hospital
City
Arkhangelsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Astrakhan
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Altay Regional Clinical Children's Hospital
City
Barnaul
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Amur Regional Clinical Children's Hospital
City
Blagoveshchensk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Bryansk Regional Children's Hospital
City
Bryansk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Chelyabinsk Regional Clinical Children's Hospital
City
Chelyabinsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Transbaikal Regional Oncology Dispensary
City
Chita
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Irkutsk Regional Children Clinical Hospital
City
Irkutsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Ivanovo Regional Clinical Hospital
City
Ivanovo
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Republic Clinical Children's Hospital
City
Izhevsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Khabarovsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Kirov Research Institute of Hematology and Blood Transfusion
City
Kirov
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Krasnodar
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Krasnoyarsk Territorial Clinical Children's Hospital
City
Krasnoyarsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Kurgan Regional Clinical Children's Hospital
City
Kurgan
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Kursk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Children's Hospital
City
Lipetsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Republic Children's Clinical Hospital
City
Makhachkala
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Morozov Children's Municipal Clinical Hospital
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Research Institute of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Russian Children's Clinical Hospital
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Murmansk Clinical Children's Hospital
City
Murmansk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Republic Clinical Children's Hospital
City
Nal'chik
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Nizhnevartovsk Regional Clinical Children's Hospital
City
Nizhnevartovsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Nizhny Novgorod
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novokuznetsk Municipal Clinical Children's Hospital N4
City
Novokuznetsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Novosibirsk Central District Clinical Hospital
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Orenburg Regional Clinical Oncology Dispensary
City
Orenburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Orël
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Perm Territorial Clinical Children's Hospital
City
Perm
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Rostov-on-Don
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Rostov Research Institute of Oncology
City
Rostov-on-Don
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
N. Dmitrieva Ryazan Regional Clinical Children's Hospital
City
Ryazan
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Almazov National Medical Research Center
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Children's Municipal Hospital N1
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Municipal Clinical Hospital N31
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
N.N.Petrov National Medical Research Oncology Center
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
R. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov First Saint-Petersburg State Medical University
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Municipal Clinical Children's Hospital N1
City
Samara
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Children's Clinical Hospital
City
Stavropol
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Surgut Regional Clinical Hospital
City
Surgut
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Republic Clinical Children's Hospital
City
Syktyvkar
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Tomsk Regional Clinical Hospital
City
Tomsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Tula Regional Clinical Children's Hospital
City
Tula
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Republic Clinical Children's Hospital
City
Ulan-Ude
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Ulyanovsk Regional Children's Clinical Hospital
City
Ulyanovsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Children's Clinical Hospital N1, Territorial Children's Hematological Center
City
Vladivostok
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Vologda Regional Clinical Children's Hospital
City
Vologda
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Voronezh Regional Clinical Children's Hospital N1
City
Voronezh
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Republic Hospital N1 - National Medicine Centre
City
Yakutsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital
City
Yaroslavl
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Regional Clinical Children's Hospital N1; Children Oncology and hematology Center
City
Yekaterinburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Research Institute of Hematology and Blood Transfusion
City
Tashkent
Country
Uzbekistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.mbstudy.net
Description
Study web-site

Learn more about this trial

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

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