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Phase I study of duvelisib in Japanese patients with relapsed or refractory lymphoma.
Int J Hematol. 2020 Jul 01 [Online ahead of print]IJ

Abstract

Duvelisib is a novel dual inhibitor of phosphoinositide-3-kinase (PI3K)-δ and -γ. This single-arm, multicenter phase I study investigated its safety, pharmacokinetics, and preliminary efficacy in Japanese patients with relapsed or refractory lymphoma. Duvelisib was administered orally twice daily at 25 mg in 28-day cycles. Seven patients, comprising 4 with follicular lymphoma (FL), 2 with diffuse large B-cell lymphoma, and 1 with mantle cell lymphoma (MCL) were enrolled. No dose-limiting toxicity occurred in any patient. The most commonly experienced treatment-related adverse events of any grade were neutropenia and thrombocytopenia, occurring in 3 patients each (42.9%); followed by lymphopenia, diarrhea, enterocolitis, stomatitis, hepatic function abnormal, ALT increased, and AST increased, occurring in 2 patients each (28.6%). The most common grade ≥ 3 treatment-related adverse events were neutropenia, which occurred in 3 patients (42.9%), and thrombocytopenia, lymphopenia, and hepatic function abnormal, which occurred in 2 patients each (28.6%). One patient with FL achieved a complete response; the remaining 3 with FL and the 1 with MCL achieved a partial response. The overall response rate was 71.4% (5/7 patients). Duvelisib was well tolerated in Japanese patients with relapsed or refractory lymphoma. Safety and preliminary efficacy data support further development of duvelisib in Japanese patients.

Authors+Show Affiliations

Department of Hematology, Toranomon Hospital, Minato-ku, Tokyo, Japan. kizutsu@ncc.go.jp. Department of Hematology, National Cancer Center Hospital, Chuo-ku, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. kizutsu@ncc.go.jp.Department of Medicine and Biosystemic Science, Faculty of Medicine, Kyusyu University, Fukuoka, Japan.Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.Department of Hematology, Toranomon Hospital, Minato-ku, Tokyo, Japan.Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.Department of Medicine and Biosystemic Science, Faculty of Medicine, Kyusyu University, Fukuoka, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32613313

Citation

Izutsu, Koji, et al. "Phase I Study of Duvelisib in Japanese Patients With Relapsed or Refractory Lymphoma." International Journal of Hematology, 2020.
Izutsu K, Kato K, Kiyoi H, et al. Phase I study of duvelisib in Japanese patients with relapsed or refractory lymphoma. Int J Hematol. 2020.
Izutsu, K., Kato, K., Kiyoi, H., Yamamoto, G., Shimada, K., & Akashi, K. (2020). Phase I study of duvelisib in Japanese patients with relapsed or refractory lymphoma. International Journal of Hematology. https://doi.org/10.1007/s12185-020-02929-3
Izutsu K, et al. Phase I Study of Duvelisib in Japanese Patients With Relapsed or Refractory Lymphoma. Int J Hematol. 2020 Jul 1; PubMed PMID: 32613313.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase I study of duvelisib in Japanese patients with relapsed or refractory lymphoma. AU - Izutsu,Koji, AU - Kato,Koji, AU - Kiyoi,Hitoshi, AU - Yamamoto,Go, AU - Shimada,Kazuyuki, AU - Akashi,Koichi, Y1 - 2020/07/01/ PY - 2020/03/12/received PY - 2020/06/24/accepted PY - 2020/06/15/revised PY - 2020/7/3/entrez KW - Clinical trial KW - Duvelisib KW - Japanese KW - Lymphoma KW - PI3K JF - International journal of hematology JO - Int. J. Hematol. N2 - Duvelisib is a novel dual inhibitor of phosphoinositide-3-kinase (PI3K)-δ and -γ. This single-arm, multicenter phase I study investigated its safety, pharmacokinetics, and preliminary efficacy in Japanese patients with relapsed or refractory lymphoma. Duvelisib was administered orally twice daily at 25 mg in 28-day cycles. Seven patients, comprising 4 with follicular lymphoma (FL), 2 with diffuse large B-cell lymphoma, and 1 with mantle cell lymphoma (MCL) were enrolled. No dose-limiting toxicity occurred in any patient. The most commonly experienced treatment-related adverse events of any grade were neutropenia and thrombocytopenia, occurring in 3 patients each (42.9%); followed by lymphopenia, diarrhea, enterocolitis, stomatitis, hepatic function abnormal, ALT increased, and AST increased, occurring in 2 patients each (28.6%). The most common grade ≥ 3 treatment-related adverse events were neutropenia, which occurred in 3 patients (42.9%), and thrombocytopenia, lymphopenia, and hepatic function abnormal, which occurred in 2 patients each (28.6%). One patient with FL achieved a complete response; the remaining 3 with FL and the 1 with MCL achieved a partial response. The overall response rate was 71.4% (5/7 patients). Duvelisib was well tolerated in Japanese patients with relapsed or refractory lymphoma. Safety and preliminary efficacy data support further development of duvelisib in Japanese patients. SN - 1865-3774 UR - https://www.unboundmedicine.com/medline/citation/32613313/Phase_I_study_of_duvelisib_in_Japanese_patients_with_relapsed_or_refractory_lymphoma L2 - https://dx.doi.org/10.1007/s12185-020-02929-3 DB - PRIME DP - Unbound Medicine ER -
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