Actively Recruiting
Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2024-06-28
80
Participants Needed
1
Research Sites
457 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at diagnosis between 1 and 365 days of life
- Start of induction therapy during the study recruitment phase
- Diagnosis of ALL confirmed by bone marrow morphological, cytochemical, and immunological analysis
- Excludes patients with B-cell (Burkitt) ALL
- Informed consent from patient parents or guardians to participate in the study
You will not qualify if you...
- Relapse of previously misdiagnosed and inadequately treated ALL
- Severe concomitant diseases that impede chemotherapy (e.g., multiple malformations, heart diseases, metabolic disorders)
- Lack of necessary data for proper chemotherapy protocol adherence or therapeutic group stratification
- Prior long-term treatment with cytotoxic drugs
- Treatment deviations not covered by the protocol or not due to side effects or disease complications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, Samory-Mashela,1, Russia, 11198
Actively Recruiting
Research Team
N
Natalya f Myakova, PD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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