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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a risk-adapted combination of chemotherapy, immunotherapy, and hematopoietic stem cell transplantation (HSCT) for infants diagnosed with B-linear Acute Lymphoblastic Leukemia (ALL) within the first year of life. The study stratifies patients into standard, intermediate, and high-risk groups based on genetic markers and minimal residual disease (MRD) levels after induction therapy. This approach aims to tailor treatment intensity to each patient's risk profile to improve outcomes. Treatment varies by risk group and MRD status. Standard risk patients without KMT2A gene rearrangement receive induction therapy with drugs including dexamethasone, vincristine, daunorubicin, and pegasparaginase, followed by consolidation and maintenance if MRD is low. Those with higher MRD levels get a course of blinatumomab and HSCT. Intermediate risk patients receive similar induction but may undergo additional chemotherapy blocks or blinatumomab and HSCT depending on MRD progression. High-risk patients receive induction therapy followed by chemotherapy blocks, blinatumomab, and HSCT regardless of remission status. Participants undergo detailed diagnostic evaluations before therapy, including bone marrow analyses. Treatment response is monitored through MRD levels to guide therapy adjustments. Researchers measure event-free and overall survival at four years, relapse risk at three years, MRD-negative remission rates after induction and consolidation, and mortality related to HSCT. The study spans from diagnosis through treatment and follow-up, with careful monitoring to assess long-term outcomes in this pediatric population.
CONDITIONS
Brief 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 acute lymphoblastic leukemia confirmed by bone marrow morphological, cytochemical, and immunological analysis
- Informed consent from patient’s parents or guardians to be treated at a study clinic
You will not qualify if you...
- Relapse of previously misdiagnosed or inadequately treated ALL
- Severe concomitant diseases that interfere with chemotherapy (such as multiple malformations, heart diseases, metabolic disorders)
- Lack of necessary data for accurate chemotherapy protocol adherence or stratification
- Previous long-term treatment with cytotoxic drugs
- Treatment deviations not covered by the protocol or unrelated to side effects or disease complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable; induction phase is 36 days with additional therapy depending on remission and risk group
Participants receive risk-adapted combined immuno-chemotherapy and hematopoietic stem cell transplantation. Treatment starts with a 36-day induction phase including dexamethasone, vincristine, daunorubicin, pegelated asparaginase, and intrathecal injections. Further therapy varies by risk group and remission status and may include consolidation, re-induction, maintenance therapies, blinatumomab, and HSCT.
Multiple visits for injections and chemotherapy over induction and subsequent therapy phases
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
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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