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Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22.

Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia.

Author information

1
University Hospital, Frankfurt, Germany.
2
University Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, University Paris Diderot, Paris, France.
3
Department of Medicine, Section of Hematology, Verona University, Verona, Italy.
4
University Hospital Regensburg, Regensburg, Germany.
5
Université Catholique de Louvain, CHU UCL Namur (Godinne), Yvoir, Belgium.
6
University Hospital and Comprehensive Cancer Center Tübingen, Universitätsklinikum Tübingen, Tübingen, Germany.
7
Department of Hematology and Oncology, Medizinische Hochschule, Hannover, Germany.
8
Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.
9
Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
10
Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
11
Amgen Research (Munich), GmbH, Munich, Germany.
12
Amgen, Ltd., Cambridge, United Kingdom.
13
Amgen, Inc., Thousand Oaks, CA; and.
14
Comprehensive Cancer Center Mainfranken, Uniklinikum Würzburg, Würzburg, Germany.

Abstract

Approximately 30% to 50% of adults with acute lymphoblastic leukemia (ALL) in hematologic complete remission after multiagent therapy exhibit minimal residual disease (MRD) by reverse transcriptase-polymerase chain reaction or flow cytometry. MRD is the strongest predictor of relapse in ALL. In this open-label, single-arm study, adults with B-cell precursor ALL in hematologic complete remission with MRD (≥10-3) received blinatumomab 15 µg/m2 per day by continuous IV infusion for up to 4 cycles. Patients could undergo allogeneic hematopoietic stem-cell transplantation any time after cycle 1. The primary end point was complete MRD response status after 1 cycle of blinatumomab. One hundred sixteen patients received blinatumomab. Eighty-eight (78%) of 113 evaluable patients achieved a complete MRD response. In the subgroup of 110 patients with Ph-negative ALL in hematologic remission, the Kaplan-Meier estimate of relapse-free survival (RFS) at 18 months was 54%. Median overall survival (OS) was 36.5 months. In landmark analyses, complete MRD responders had longer RFS (23.6 vs 5.7 months; P = .002) and OS (38.9 vs 12.5 months; P = .002) compared with MRD nonresponders. Adverse events were consistent with previous studies of blinatumomab. Twelve (10%) and 3 patients (3%) had grade 3 or 4 neurologic events, respectively. Four patients (3%) had cytokine release syndrome grade 1, n = 2; grade 3, n = 2), all during cycle 1. After treatment with blinatumomab in a population of patients with MRD-positive B-cell precursor ALL, a majority achieved a complete MRD response, which was associated with significantly longer RFS and OS compared with MRD nonresponders. This study is registered at www.clinicaltrials.gov as #NCT01207388.

PMID:
29358182
PMCID:
PMC6027091
DOI:
10.1182/blood-2017-08-798322
[Indexed for MEDLINE]
Free PMC Article

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