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Bending the Curve Trial by Trial
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A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

Phase 1/2N = 93NCT01471782

Population
Children younger than 18 years with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Design
Open-label phase I dosage-escalation part (49 patients) and phase II part (44 patients), using 6-week treatment cycles of single-agent blinatumomab. Primary end points were maximum-tolerated dosage (phase I) and complete remission rate within the first two cycles (phase II). Recommended dosage: 5 µg/m2/d for the first 7 days, then 15 µg/m2/d.
Primary endpoint
Complete remission rate
Arms
  • Blinatumomab (experimental, n = 93): Blinatumomab, 6-week cycles; recommended dosage 5 µg/m2/d for 7 days then 15 µg/m2/d
People
von Stackelberg A, senior author Gore L
Show the numbers
Results reported for A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
EndpointAnalysisBlinatumomabControlEffect
Complete remission ratePatients who received the recommended dosage (70)Complete remission within the first two cyclesprimaryvon 201639% (27–51%)—27 of 70 patients; the abstract pools patients from the phase I and phase II parts who received the recommended dosage.
MRD-negative remission ratePatients in complete remission at the recommended dosage (27)Complete minimal residual disease response among patients in complete remissionprimaryvon 201652%—14 of 27 patients in complete remission.
Results reported for A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
EndpointAnalysisBlinatumomabControlEffect
Complete remission ratePatients who received the recommended dosage (70)Complete remission within the first two cyclesprimaryvon 201639% (27–51%)—27 of 70 patients; the abstract pools patients from the phase I and phase II parts who received the recommended dosage.
MRD-negative remission ratePatients in complete remission at the recommended dosage (27)Complete minimal residual disease response among patients in complete remissionprimaryvon 201652%—14 of 27 patients in complete remission.
Primary publication: von Stackelberg A, Locatelli F, Zugmaier G, Handgretinger R, Trippett TM, Rizzari C, et al. Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Oncol. 2016;34(36):4381-4389. PubMedDOI

Appears in

Sources

  1. von Stackelberg A, Locatelli F, Zugmaier G, Handgretinger R, Trippett TM, Rizzari C, et al. Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Oncol. 2016;34(36):4381-4389.

    PubMedDOI