An interventional study of Blinatumomab in Childhood Acute Lymphoblastic Leukemia, sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. Status unknown at 4 sites in Russia. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Not applicable, Interventional, and Treatment
THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy.
QUESTIONS AND OBJECTIVES OF THE STUDY:
2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.
This study's planned enrollment of 180 is above the median of 40 across 1,691 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Federal Research Institute of Pediatric Hematology, Oncology and Immunology is the lead sponsor of 57 studies on the registry; 18 are open to participants now.
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This study included patients with B-cell precursor ALL (BCP-ALL) diagnosed or confirmed in one of the clinics participating in the study. Also following criteria should be considered at the diagnosis for each case:
Exclusion Criteria:
Consolidation therapy with Blinatumomab administration
Drug: Blinatumomab
Blinatumomab, intravenously, as continuous 24 hours infusion 1-7 days - 5 μg/m2/day, 8-28 day - 15 μg/m2/day 1 course after induction treatment
Minimal residual disease level
Time frame: On the last day of the blinatumomab course, on average at 11 weeks of protocol
Minimal residual disease level
Time frame: 6 months after starting maintenance therapy
Minimal residual disease level
Time frame: 1 year after starting maintenance therapy
Event-free survival
Time frame: 3 years after study start
Event-free survival
Time frame: 5 years after study start
Overall survival
Time frame: 3 years after study start
Overall survival
Time frame: 5 years after study start
Cumulative incidence of relapse
Time frame: 3 years after study start
Cumulative incidence of relapse
Time frame: 5 years after study start
Remission death rate
Time frame: 3 years after study start
Remission death rate
Time frame: 5 years after study start
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Blinatumomab
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Federal Research Institute of Pediatric Hematology, Oncology and Immunology