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New treatment protocol for childhood acute lymphoblastic leukemia

Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults

Not applicable Interventional Federal Research Institute of Pediatric Hematology, Oncology and Immunology · NCT03390387

This study is testing a new treatment plan for children and young adults with acute lymphoblastic leukemia to see if it can help them live longer and healthier by using different chemotherapy drugs.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment4000 (estimated)
Ages1 Year to 50 Years
SexAll
SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology Academic / other
Drugs / interventionschemotherapy
Locations58 sites (Ereván and 57 other locations)
Trial IDNCT03390387 on ClinicalTrials.gov

What this trial studies

This study evaluates a new treatment protocol for childhood acute lymphoblastic leukemia (ALL) that includes risk group stratification and various chemotherapy regimens. It aims to improve overall and event-free survival rates, particularly for patients older than 15 years and young adults. The protocol investigates the effects of intermittent dexamethasone administration, the use of methylprednisolone, and the addition of Bortezomib and Idarubicin in specific patient groups. The study will assess the feasibility and efficacy of these interventions in a multicenter setting across several locations.

Who should consider this trial

Good fit: Ideal candidates are patients aged 1 to 50 years diagnosed with acute lymphoblastic leukemia who can start induction therapy within the study recruitment phase.

Not a fit: Patients with second malignancies, relapsed ALL, or severe concomitant diseases that impede chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this protocol could significantly improve survival rates and reduce treatment-related toxicity for children and young adults with ALL.

How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific protocol is novel in its comprehensive risk stratification and treatment combinations.

Eligibility criteria

Show full 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

Where this trial is running

Ereván and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Childhood Acute Lymphoblastic LeukemiaAcute lymphoblastic leukemia, children, adolescents, treatment
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.