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Re‐induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL): Phase II results from Children's Oncology Group (COG) study ADVL04P2
Author(s) -
Raetz Elizabeth A.,
Cairo Mitchell S.,
Borowitz Michael J.,
Lu Xiaomin,
Devidas Meenakshi,
Reid Joel M.,
Goldenberg David M.,
Wegener William A.,
Zeng Hui,
Whitlock James A.,
Adamson Peter C.,
Hunger Stephen P.,
Carroll William L.
Publication year - 2015
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.25454
Subject(s) - medicine , chemoimmunotherapy , induction chemotherapy , chemotherapy , oncology , regimen , cog , minimal residual disease , chemotherapy regimen , bone marrow , cyclophosphamide , artificial intelligence , computer science
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 (360 mg/m 2 /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. © 2015 Wiley Periodicals, Inc.