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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03390387
• Date of registration: 27/12/2017
• Prospective Registration: No
• Primary sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Public title: Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015) ALL-MB 2015
• Scientific title: Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
• Date of first enrolment: November 2015
• Target sample size: 4000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03390387
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Armenia, Belarus, Kyrgyzstan, Russian Federation, Uzbekistan

Contacts

• Name: Alexander I. Karachunskiy, Professor, MD
• Affiliation: Research Institute of Pediatric Hematology, Oncology and Immunology

• Name: Alexander I. Karachunskiy, Professor, MD

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Childhood Acute Lymphoblastic Leukemia

Intervention(s)

Drug: Standard induction therapy

Drug: Dexamethasone

Drug: Daunorubicin

Drug: Idarubicin

Drug: Second phase of induction

Drug: Dexamethasone continuous

Drug: Dexamethasone intermittent

Drug: Standard consolidation therapy

Drug: Bortezomib

Drug: Methylprednisolone

Primary Outcome(s)

Overall survival [Time Frame: 3 years, 5 years and 10 years after study start]

Cumulative incidence of relapse [Time Frame: 3 years, 5 years and 10 years after study start]

Event-free survival [Time Frame: 3 years, 5 years and 10 years after study start]

Secondary Outcome(s)

Early death rate [Time Frame: 3 years, 5 years and 10 years after study start]

Remission death rate [Time Frame: 3 years, 5 years and 10 years after study start]

Secondary ID(s)

ALL-MB 2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors