Combined immuno-chemotherapy for infants with acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on infants diagnosed with acute lymphoblastic leukemia (ALL) and employs a risk-adapted approach to treatment. Patients are stratified into risk groups based on genetic factors and response to initial therapy, with tailored interventions including chemotherapy, immunotherapy, and hematopoietic stem cell transplantation for those with high-risk features. The study aims to optimize treatment outcomes by adjusting therapy based on individual patient risk profiles and response to induction therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age at diagnosis at 1 to 365 days of life.
* 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 study.

Exclusion Criteria:

* 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 it's running

• Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
  Moscow, Samory-Mashela,1, Russia Recruiting

Study contacts

• Study coordinator: Natalya f Myakova, PD
• Email: Natalya.Myakova@fccho-moscow.ru
• Phone: +79035083576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.