Re-induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL): Phase II results from Children's Oncology Group (COG) study ADVL04P2

Elizabeth A. Raetz, Mitchell S. Cairo, Michael J. Borowitz, Xiaomin Lu, Meenakshi Devidas, Joel M. Reid, David M. Goldenberg, William A. Wegener, Hui Zeng, James A. Whitlock, Peter C. Adamson, Stephen P. Hunger, William L. Carroll

Research output: Contribution to journalArticlepeer-review

48 Scopus citations

Abstract

Background: Given the success of immunotherapeutic approaches in hematologic malignancies, the COG designed a phase I/II study to determine whether the addition of epratuzumab (anti-CD22) to an established chemotherapy platform improves rates of second remission (CR2) in pediatric patients with B-lymphoblastic leukemia (B-ALL) and early bone marrow relapse. Procedure: Therapy consisted of three established blocks of re-induction chemotherapy. Epratuzumab (360mg/m2/dose) was combined with chemotherapy on weekly×4 (B1) and twice weekly×4 [eight doses] (B2) schedules during the first re-induction block. Remission rates and minimal residual disease (MRD) status were compared to historical rates observed with the identical chemotherapy platform alone. Results: CR2 was achieved in 65 and 66%, of the evaluable B1 (n=54) and B2 patients (n=60), respectively; unchanged from that observed historically without epratuzumab. Rates of MRD negativity (<0.01%) were 31% in B1 (P=0.4128) and 39% in B2 patients (P=0.1731), compared to 25% in historical controls. The addition of epratuzumab was well tolerated, with a similar toxicity profile to that observed with the re-induction chemotherapy platform regimen alone. Conclusions: Epratuzumab was well tolerated in combination with re-induction chemotherapy. While CR2 rates were not improved compared to historical controls treated with chemotherapy alone, there was a non-significant trend towards improvement in MRD response with the addition of epratuzumab (twice weekly for eight doses) to re-induction chemotherapy. Pediatr Blood Cancer 2015;62:1171-1175.

Original languageEnglish (US)
Pages (from-to)1171-1175
Number of pages5
JournalPediatric Blood and Cancer
Volume62
Issue number7
DOIs
StatePublished - Jul 1 2015

Keywords

  • Epratuzumab
  • Monoclonal antibody
  • Relapsed ALL

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

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