A phase 2 trial of CHOP with anti-CCR4 antibody mogamulizumab for older patients with adult T-cell leukemia/lymphoma

No standard of care for older patients with aggressive adult T-cell leukemia/lymphoma (ATL) has been established. We evaluated the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) every 2 weeks with mogamulizumab (Moga; Moga-CHOP-14) for older patients with untreated ATL. In this multicenter phase 2 trial, patients aged ≥66 years and those aged 56 to 65 years ineligible for transplantation received 6 cycles of Moga-CHOP-14, followed by 2 cycles of Moga monotherapy. The primary end point was 1-year progression-free survival (PFS). Secondary end points were the complete response (CR) rate, overall response rate (ORR), overall survival (OS), 1-year event-free survival (EFS), and safety. We also investigated the impact of CC chemokine receptor 4 (CCR4) mutation and Moga-associated cutaneous adverse events (cAEs) on PFS and OS. The study protocol was amended to allow the dosing interval to be extended to 21 days at the physician's discretion. Among 48 evaluable patients, the 1-year PFS was 36.2% (90% confidence interval, 24.9-47.6), with a median follow-up of 1.6 years. The 1-year OS and EFS were 66.0% and 29.9%, respectively. CR and ORR were 64.6% and 91.7%. No unexpected toxicities were observed. Of 47 patients who received ≥2 cycles of CHOP, 20 (42.6%) received CHOP-14, among whom 12 (25.5%) completed 6 cycles. CCR4 mutation and Moga-associated cAEs were associated with better OS. This study showed that Moga-CHOP significantly improved PFS, although the optimal interval for CHOP remains undetermined. Moga-CHOP is now considered a preferable first-line treatment for this patient population. This trial was registered at https://jrct.mhlw.go.jp/en-top as #jRCTs041180130.

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Journal
Blood
Published
2025-05-15
DOI
https://doi.org/10.1182/blood.2024027902
Citations
15
Primary Topic
T-cell and Retrovirus Studies
Type
article
Field-Weighted Citation Impact
11.96

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article

A phase 2 trial of CHOP with anti-CCR4 antibody mogamulizumab for older patients with adult T-cell leukemia/lymphoma

Satsuki Owatari, Shinya Rai, Hiroshi Inagaki, Shinobu Tamura et al.
15 citations
Blood
T-cell and Retrovirus Studies
11.96
article

A phase 2 trial of CHOP with anti-CCR4 antibody mogamulizumab for older patients with adult T-cell leukemia/lymphoma

Satsuki Owatari, Shinya Rai, Hiroshi Inagaki, Shinobu Tamura, Shigeru Kusumoto, Mototsugu Shimokawa, Yuma Sakamoto, Tomonori Hidaka, Takashi Ishida, Atae Utsunomiya, Kisato Nosaka, Kenji Ishitsuka, Masaaki Sekine, Makoto Yoshimitsu, Ilseung Choi, Masahito Tokunaga, Daisuke Nakamura, Ki‐Ryang Koh, Hidenori Sasaki, Youko Suehiro
article en
15 citations

Abstract

No standard of care for older patients with aggressive adult T-cell leukemia/lymphoma (ATL) has been established. We evaluated the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) every 2 weeks with mogamulizumab (Moga; Moga-CHOP-14) for older patients with untreated ATL. In this multicenter phase 2 trial, patients aged ≥66 years and those aged 56 to 65 years ineligible for transplantation received 6 cycles of Moga-CHOP-14, followed by 2 cycles of Moga monotherapy. The primary end point was 1-year progression-free survival (PFS). Secondary end points were the complete response (CR) rate, overall response rate (ORR), overall survival (OS), 1-year event-free survival (EFS), and safety. We also investigated the impact of CC chemokine receptor 4 (CCR4) mutation and Moga-associated cutaneous adverse events (cAEs) on PFS and OS. The study protocol was amended to allow the dosing interval to be extended to 21 days at the physician's discretion. Among 48 evaluable patients, the 1-year PFS was 36.2% (90% confidence interval, 24.9-47.6), with a median follow-up of 1.6 years. The 1-year OS and EFS were 66.0% and 29.9%, respectively. CR and ORR were 64.6% and 91.7%. No unexpected toxicities were observed. Of 47 patients who received ≥2 cycles of CHOP, 20 (42.6%) received CHOP-14, among whom 12 (25.5%) completed 6 cycles. CCR4 mutation and Moga-associated cAEs were associated with better OS. This study showed that Moga-CHOP significantly improved PFS, although the optimal interval for CHOP remains undetermined. Moga-CHOP is now considered a preferable first-line treatment for this patient population. This trial was registered at https://jrct.mhlw.go.jp/en-top as #jRCTs041180130.

BloodVol. 146(12)
Kagoshima University (JP), University of Miyazaki (JP), Yamaguchi University (JP), Wakayama Medical University (JP), Fukuoka University (JP), Nagoya City University (JP), Fukuoka University Hospital (JP), National Hospital Organization Kyushu Cancer Center (JP), Kindai University Hospital (JP), Osaka City General Hospital (JP), Kagoshima University Hospital (JP), Kumamoto University Hospital (JP), Imamura Hospital (JP), Aichi Cancer Center (JP), National Hospital Organization (JP), Kagoshima Medical Center (JP), Nagoya University (JP), Kindai University (JP)
Bristol-Myers Squibb, Eli Lilly and Company, Sanofi, Kagoshima University, Japan Agency for Medical Research and Development, Kissei, Nippon Shinyaku, Eisai, Meiji Seika Pharma, Astellas Pharma, Fukuoka University, Nagoya City University, Saitama Medical University, Ono Pharmaceutical, Chugai Pharmaceutical, Daiichi Sankyo Europe
Good health and well-being
Openalex Percentile: Top 1%
T-cell and Retrovirus Studies
11.96
DOIOpen Access PDFOpenAlex
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