Assessment of Outcomes of Consolidation Therapy By Number of Cycles of Blinatumomab Received in Newly Diagnosed Measurable Residual Disease Negative Patients with B-Lineage Acute Lymphoblastic Leukemia: In the ECOG-ACRIN E1910 Randomized Phase III National Clinical Trials Network Trial

作者：Selina M. Luger, Zhuoxin Sun, Ryan J. Mattison, Elisabeth Paietta, Kathryn G. Roberts, Yanming Zhang, Janis Racevckis, Hillard M. Lazarus, Jacob M. Rowe, Daniel A. Arber, Matthew J. Wieduwilt, Michaela Liedtke, Julie Bergeron, Brent L. Wood, Yaqi Zhao, Gang Wu, Ti‐Cheng Chang, Wenchao Zhang, Keith W. Pratz, Shira Dinner, Noelle V. Frey, Steven D. Gore, Bhavana Bhatnagar, Ehab Atallah, Geoffrey L. Uy, Deepa Jeyakumar, Tara L. Lin, Cheryl L. Willman, Daniel J. DeAngelo, Elad Sharon, Richard F. Little, Harry P. Erba, Richard M. Stone, Charles G. Mullighan, Mark R. Litzow, Martin S. Tallman · 发表于：Blood · 年份：2023 · DOI：10.1182/blood-2023-189648 · 被引用次数：14 · 研究领域：Acute Lymphoblastic Leukemia research、Chronic Myeloid Leukemia Treatments、Pharmaceutical studies and practices

Introduction: ECOG ACRIN E1910 is a randomized phase III trial that showed that adults with newly diagnosed BCR::ABL1 negative acute lymphoblastic leukemia (ALL) who become MRD negative (<0.01%) after induction chemo who receive blinatumomab with conventional chemotherapy (chemo) have improved survival compared with those who received chemo only (Litzow et al, Blood (2022) 140: Supplement 2, LBA-1). However, not all pts were able to receive all four planned cycles of blinatumomab in consolidation. In this report we assessed outcomes of pts in the blinatumomab arm of the trial who received all 4 cycles of blinatumomab compared to those who received 1-2 cycles. Methods: Patient between the ages of 30 and 70 with newly diagnosed BCR::ABL1 negative B-lineage ALL were enrolled and initially received 2.5 months of combination induction chemo utilizing a BFM-like regimen adapted from the E2993/UKALLXII clinical trial, with pegaspargase (after induction only for patients >=55 years of age) and addition of rituximab for CD20 positive patients. After remission induction (step 1) pts in morphologic complete remission (CR/CRi) received an intensification course of high dose methotrexate with pegaspargase for CNS prophylaxis (step 2). At the conclusion of step 2, remission and MRD status were determined centrally by 6-color flow cytometry with MRD negativity defined as <0.01%. In the primary analysis subset, MRD negative patients were randomized to receive an addition...