Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01953770
• Date of registration: 26/09/2013
• Prospective Registration: No
• Primary sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Public title: Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008 ALL-MB 2008
• Scientific title: Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents
• Date of first enrolment: February 2008
• Target sample size: 3000
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01953770
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belarus, Russian Federation, Uzbekistan

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age at diagnosis at 1 to 18 years.

2. The start of induction therapy within a time interval of study recruitment phase.

3. The diagnosis of ALL is to be proved by the morphological, cytochemical, and
immunological analysis of tumor cells in bone marrow.

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

Exclusion Criteria:

1. ALL is a second malignant tumor;

2. The disease is a relapse of previously misdiagnosed and, therefore, inadequately
treated ALL;

3. There is severe concomitant disease, which significantly impedes chemotherapy protocol
(such as multiple malformations, heart diseases, metabolic disorders, etc.);

4. There is a lack of important basic data needed for the exact adherence to the
cytostatic therapy according to a specific protocol of chemotherapy (differential
diagnosis of acute lymphoblastic/myeloid leukemia is not possible, stratification
according to risk group is not possible);

5. The patient was treated before for a long time with cytotoxic drugs;

6. There were deviations in the treatment 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: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Childhood Acute Lymphoblastic Leukemia

Intervention(s)

Radiation: Cranial irradiation

Drug: E.coli L-asparaginase

Drug: PEG-L-asparaginase ind

Drug: Triple intrathecal therapy

Drug: High-dose Methotrexate

Drug: Daunorubicin

Drug: Low-dose Methotrexate

Drug: PEG-L-asparaginase cons

Primary Outcome(s)

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]

overall 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 2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors