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AALL1621

A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Phase 2N = 48NCT02981628

Population
Patients aged 1 to 21 years with relapsed or refractory CD22-positive B-ALL
Design
Single-arm phase 2 trial of the Children's Oncology Group with a two-stage design, continuously monitored for dose-limiting toxicities and sinusoidal obstruction syndrome. Inotuzumab ozogamicin 0.8 mg/m2 intravenously on day 1 and 0.5 mg/m2 on days 8 and 15 of a 28-day cycle, with response evaluation at day 28. 48 patients were evaluable for response and toxicity (ClinicalTrials.gov lists an estimated enrollment of 80).
Arms
  • Inotuzumab ozogamicin (experimental, n = 48): 0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15 of a 28-day cycle
People
O'Brien MM, senior author Loh ML, Children's Oncology Group
Show the numbers
Results reported for AALL1621
EndpointAnalysisInotuzumab ozogamicinControlEffect
Overall remission ratePatients evaluable for response and toxicity (48)Complete response (CR) or CR with incomplete count recovery (CRi) after cycle 1primaryO'Brien 202258.3%—19 CR and 9 CRi; two-sided 90% CI 46.5 to 69.3 (a 90% interval, not 95%).
MRD-negative remission rateResponders with MRD measured by flow cytometry (27)Minimal residual disease below 0.01% by flow cytometry among patients with CR or CRiprimaryO'Brien 202266.7%—18 of 27 patients; 27 of the 28 patients with CR or CRi had MRD measured.
Results reported for AALL1621
EndpointAnalysisInotuzumab ozogamicinControlEffect
Overall remission ratePatients evaluable for response and toxicity (48)Complete response (CR) or CR with incomplete count recovery (CRi) after cycle 1primaryO'Brien 202258.3%—19 CR and 9 CRi; two-sided 90% CI 46.5 to 69.3 (a 90% interval, not 95%).
MRD-negative remission rateResponders with MRD measured by flow cytometry (27)Minimal residual disease below 0.01% by flow cytometry among patients with CR or CRiprimaryO'Brien 202266.7%—18 of 27 patients; 27 of the 28 patients with CR or CRi had MRD measured.
Primary publication: O'Brien MM, Ji L, Shah NN, Rheingold SR, Bhojwani D, Yuan CM, et al. Phase II Trial of Inotuzumab Ozogamicin in Children and Adolescents With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: Children's Oncology Group Protocol AALL1621. J Clin Oncol. 2022;40(9):956-967. PubMedDOI

Appears in

Sources

  1. O'Brien MM, Ji L, Shah NN, Rheingold SR, Bhojwani D, Yuan CM, et al. Phase II Trial of Inotuzumab Ozogamicin in Children and Adolescents With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: Children's Oncology Group Protocol AALL1621. J Clin Oncol. 2022;40(9):956-967.

    PubMedDOI