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 language | English |
|---|---|
| Pages (from-to) | 655-665 |
| Number of pages | 11 |
| Journal | International journal of hematology |
| Volume | 106 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Nov 1 2017 |
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All Science Journal Classification (ASJC) codes
- Hematology
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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 journal › Article
}
TY - JOUR
T1 - Romidepsin in Japanese patients with relapsed or refractory peripheral T-cell lymphoma
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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85021728257&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85021728257&partnerID=8YFLogxK
U2 - 10.1007/s12185-017-2286-1
DO - 10.1007/s12185-017-2286-1
M3 - Article
C2 - 28664499
AN - SCOPUS:85021728257
VL - 106
SP - 655
EP - 665
JO - International Journal of Hematology
JF - International Journal of Hematology
SN - 0925-5710
IS - 5
ER -