Romidepsin in Japanese patients with relapsed or refractory peripheral T-cell lymphoma

a phase I/II and pharmacokinetics study

Dai Maruyama, Kensei Tobinai, Michinori Ogura, Toshiki Uchida, Kiyohiko Hatake, Masafumi Taniwaki, Kiyoshi Ando, Kunihiro Tsukasaki, Takashi Ishida, Naoki Kobayashi, Kenichi Ishizawa, Yoichi Tatsumi, Koji Kato, Toru Kiguchi, Takayuki Ikezoe, Eric Laille, Tokihiro Ro, Hiromi Tamakoshi, Sanae Sakurai, Tomoko Ohtsu

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

This phase I/II multicenter study evaluated romidepsin treatment in Japanese patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). Patients aged ≥20 years received romidepsin via a 4-h intravenous infusion on days 1, 8, and 15 of each 28-day cycle. Phase I used a 3 + 3 design to identify any dose-limiting toxicity (DLT) for regimens of romidepsin 9 and 14 mg/m2. The primary endpoints for phase I and II were DLT and overall response rate (ORR), respectively. Intent-to-treat patients were those who received ≥1 romidepsin dose (PTCL, n = 48; CTCL, n = 2). In phase I, none of the patients (n = 3, 9 mg/m2; n = 6, 14 mg/m2) exhibited DLT. In phase II, 40 patients with PTCL were treated with 14 mg/m2 romidepsin. The most common treatment-emergent grade ≥3 adverse events were lymphopenia (74%), neutropenia (54%), leukopenia (46%), and thrombocytopenia (38%). Patients in phase II showed a 43% ORR, including 25% complete responses. Median progression-free survival was 5.6 months and median duration of response was 11.1 months. This phase I/II study identified a well-tolerated dose of romidepsin, with an acceptable toxicity profile and clinically meaningful efficacy in Japanese patients with relapsed/refractory PTCL. ClinicalTrials.gov Identifier NCT01456039.

Original languageEnglish
Pages (from-to)655-665
Number of pages11
JournalInternational journal of hematology
Volume106
Issue number5
DOIs
Publication statusPublished - Nov 1 2017

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Peripheral T-Cell Lymphoma
Pharmacokinetics
Cutaneous T-Cell Lymphoma
Lymphopenia
Leukopenia
romidepsin
Neutropenia
Intravenous Infusions
Thrombocytopenia
Multicenter Studies
Disease-Free Survival
Therapeutics

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Romidepsin in Japanese patients with relapsed or refractory peripheral T-cell lymphoma : a phase I/II and pharmacokinetics study. / Maruyama, Dai; Tobinai, Kensei; Ogura, Michinori; Uchida, Toshiki; Hatake, Kiyohiko; Taniwaki, Masafumi; Ando, Kiyoshi; Tsukasaki, Kunihiro; Ishida, Takashi; Kobayashi, Naoki; Ishizawa, Kenichi; Tatsumi, Yoichi; Kato, Koji; Kiguchi, Toru; Ikezoe, Takayuki; Laille, Eric; Ro, Tokihiro; Tamakoshi, Hiromi; Sakurai, Sanae; Ohtsu, Tomoko.

In: International journal of hematology, Vol. 106, No. 5, 01.11.2017, p. 655-665.

Research output: Contribution to journalArticle

Maruyama, D, Tobinai, K, Ogura, M, Uchida, T, Hatake, K, Taniwaki, M, Ando, K, Tsukasaki, K, Ishida, T, Kobayashi, N, Ishizawa, K, Tatsumi, Y, Kato, K, Kiguchi, T, Ikezoe, T, Laille, E, Ro, T, Tamakoshi, H, Sakurai, S & Ohtsu, T 2017, 'Romidepsin in Japanese patients with relapsed or refractory peripheral T-cell lymphoma: a phase I/II and pharmacokinetics study', International journal of hematology, vol. 106, no. 5, pp. 655-665. https://doi.org/10.1007/s12185-017-2286-1
Maruyama, Dai ; Tobinai, Kensei ; Ogura, Michinori ; Uchida, Toshiki ; Hatake, Kiyohiko ; Taniwaki, Masafumi ; Ando, Kiyoshi ; Tsukasaki, Kunihiro ; Ishida, Takashi ; Kobayashi, Naoki ; Ishizawa, Kenichi ; Tatsumi, Yoichi ; Kato, Koji ; Kiguchi, Toru ; Ikezoe, Takayuki ; Laille, Eric ; Ro, Tokihiro ; Tamakoshi, Hiromi ; Sakurai, Sanae ; Ohtsu, Tomoko. / Romidepsin in Japanese patients with relapsed or refractory peripheral T-cell lymphoma : a phase I/II and pharmacokinetics study. In: International journal of hematology. 2017 ; Vol. 106, No. 5. pp. 655-665.
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T2 - a phase I/II and pharmacokinetics study

AU - Maruyama, Dai

AU - Tobinai, Kensei

AU - Ogura, Michinori

AU - Uchida, Toshiki

AU - Hatake, Kiyohiko

AU - Taniwaki, Masafumi

AU - Ando, Kiyoshi

AU - Tsukasaki, Kunihiro

AU - Ishida, Takashi

AU - Kobayashi, Naoki

AU - Ishizawa, Kenichi

AU - Tatsumi, Yoichi

AU - Kato, Koji

AU - Kiguchi, Toru

AU - Ikezoe, Takayuki

AU - Laille, Eric

AU - Ro, Tokihiro

AU - Tamakoshi, Hiromi

AU - Sakurai, Sanae

AU - Ohtsu, Tomoko

PY - 2017/11/1

Y1 - 2017/11/1

N2 - This phase I/II multicenter study evaluated romidepsin treatment in Japanese patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). Patients aged ≥20 years received romidepsin via a 4-h intravenous infusion on days 1, 8, and 15 of each 28-day cycle. Phase I used a 3 + 3 design to identify any dose-limiting toxicity (DLT) for regimens of romidepsin 9 and 14 mg/m2. The primary endpoints for phase I and II were DLT and overall response rate (ORR), respectively. Intent-to-treat patients were those who received ≥1 romidepsin dose (PTCL, n = 48; CTCL, n = 2). In phase I, none of the patients (n = 3, 9 mg/m2; n = 6, 14 mg/m2) exhibited DLT. In phase II, 40 patients with PTCL were treated with 14 mg/m2 romidepsin. The most common treatment-emergent grade ≥3 adverse events were lymphopenia (74%), neutropenia (54%), leukopenia (46%), and thrombocytopenia (38%). Patients in phase II showed a 43% ORR, including 25% complete responses. Median progression-free survival was 5.6 months and median duration of response was 11.1 months. This phase I/II study identified a well-tolerated dose of romidepsin, with an acceptable toxicity profile and clinically meaningful efficacy in Japanese patients with relapsed/refractory PTCL. ClinicalTrials.gov Identifier NCT01456039.

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