Status:
UNKNOWN
Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-50 years
Phase:
NA
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 fea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT03390387
Start Date
November 1 2015
End Date
November 1 2025
Last Update
February 5 2020
Active Locations (58)
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1
prof. R.O.Eolyan Hematology Center
Yerevan, Armenia
2
Republican Research and Practical Center of Radiation Medicine and Human Ecology
Homyel, Belarus
3
Republic Research and Practical Center of Pediatric Oncology, Hematology and Immunology
Minsk, Belarus
4
Mogilev Regional Children's Hospital
Mogilev, Belarus