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Pediatr Blood Cancer. 2015 Jul;62(7):1171-5. doi: 10.1002/pbc.25454. Epub 2015 Mar 2.

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

Author information

1
Department of Pediatrics and Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.
2
Department of Pediatrics, New York Medical College, New York, New York.
3
Department of Pathology, Johns Hopkins University, Baltimore, Maryland.
4
Department of Biostatistics, Colleges of Medicine, Public Health & Health Professions, University of Florida, Gainesville, Florida.
5
Department of Oncology, Mayo Clinic, Rochester, Minnesota.
6
Immunomedics, Inc., Morris Plains, New Jersey.
7
Department of Pediatrics, University of Toronto and the Hospital for Sick Children, Toronto, Ontario.
8
Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
9
NYU Perlmutter Cancer Center and Department of Pediatrics, NYU Langone Medical Center, New York, New York.

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 (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.

KEYWORDS:

epratuzumab; monoclonal antibody; relapsed ALL

PMID:
25732247
PMCID:
PMC4701208
DOI:
10.1002/pbc.25454
[Indexed for MEDLINE]
Free PMC Article

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