A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-… (NCT07223190) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia
560 participantsStarted 2026-06-11
Plain-language summary
The main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with chemotherapy (Arm A) in overall survival (OS) in newly diagnosed participants with Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in complete remission (CR) or CR with incomplete peripheral count recovery (CRi) after induction.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL).
* Age ≥18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2, higher ECOG score allowed if due to underlying leukemia.
* Adequate organ function as described below:
* Renal: estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m\^2 per the Modification of Diet in Renal Disease for adult participants equation
* Hepatic function: total bilirubin ≤3.0 mg/dL prior to start of treatment; unless due to Gilbert's Disease or if liver involvement with leukemia
* Cardiac: left ventricular ejection fraction (LVEF) ≥50% and no clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thromboembolism (VTE) disease.
Exclusion Criteria:
Other Medical Conditions
* Isolated extramedullary disease.
* History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis.
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
* History of other malignancy within the past 3 years, except for malignancy treated with curative intent with low risk for recurrence. Exceptions include:
* Adequately tre…