NCT05029531 Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)
| NCT ID | NCT05029531 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
| Condition | Acute Lymphoblastic Leukemia, Pediatric |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-09-23 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2021-09-23 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The innovation of this protocol is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. Investigators have proposed a two-stage stratification into risk groups: Initially: * Standard risk: patients with no rearrangement of the KMT2A gene. * Intermediate risk: patients with rearrangement of the KMT2A gene without damage to the central nervous system. * High risk: patients with rearrangement of the KMT2A gene with lesions of the central nervous system. According to the results of induction therapy: * The high-risk group includes patients from the standard risk group with an MRD level of more than 0.1% after the induction course and from the intermediate risk group with MRD-positive (PCR) after HR1 block. * The allocation of children in the first year of life without the rearranged KMT2A gene into a separate group seems to be logical, since the prognosis in this group is better than in children with the rearranged KMT2A gene. In this protocol, non-intensive therapy with consolidations and maintenance therapy remains for those who achieve a low MRD level (less than 0.1%) after a course of induction. The rest of the patients move into a high-risk group: they receive blinatumomab and HSCT. * The concept of therapy for patients at intermediate risk is based on the rate at which MRD-negativity is achieved: standard consolidation and maintenance therapy for those who became MRD-negative at the end of induction, "block" chemotherapy for those who were positive at the end of induction, but achieved negativity after HR1 block, blinatumomab with HSCT for those who have preserved the MRD after the HR1 block. * For high-risk patients, a combination of immunotherapy (blinatumomab - a bispecific CD3 / CD19 T-cell activator) and HSCT in the first remission was chosen.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05029531 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 365 Days, studying Acute Lymphoblastic Leukemia, Pediatric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05029531 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT05029531 currently recruiting?
Yes, NCT05029531 is actively recruiting participants. Contact the research team at Natalya.Myakova@fccho-moscow.ru for enrollment information.
Where is the NCT05029531 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT05029531 clinical trial?
NCT05029531 is sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. The trial plans to enroll 80 participants.
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