Combined immuno-chemotherapy for infants with acute lymphoblastic leukemia
Prospective Single Group Study Combined Immuno-hemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)
This study is testing a new treatment approach for infants with acute lymphoblastic leukemia to see if customizing their therapy based on their specific risks and responses can improve their chances of recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Day to 365 Days |
| Sex | All |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology Academic / other |
| Drugs / interventions | chemotherapy, blinatumomab, immunotherapy, methotrexate |
| Locations | 1 site (Moscow, Samory-Mashela,1) |
| Trial ID | NCT05029531 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants aged 1 to 365 days diagnosed with acute lymphoblastic leukemia.
Not a fit: Patients with relapsed ALL or severe concomitant diseases that hinder chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for infants with ALL.
How similar studies have performed: Other studies have shown promise with similar risk-adapted treatment approaches in pediatric leukemia, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Moscow, Samory-Mashela,1
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.