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

  • STATUS
    Recruiting
  • End date
    Nov 23, 2025
  • participants needed
    4000
  • sponsor
    Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Updated on 23 January 2021
lymphoid leukemia
adult t-cell leukemia/lymphoma
daunorubicin
b-cell acute lymphoblastic leukemia
childhood all
dexamethasone

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 WBC100,000/l 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?

Details
Condition childhood ALL, Lymphocytic Leukemia, Acute, Lymphocytic Leukemia, Acute
Treatment Methylprednisolone, Dexamethasone, Bortezomib, Idarubicin, Daunorubicin, Dexamethasone continuous, Dexamethasone intermittent, Second phase of induction, Standard induction therapy, Standard consolidation therapy
Clinical Study IdentifierNCT03390387
SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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