{"doi":"10.1002/hon.3163_125","title":"A PHASE 2 TRIAL OF CHOP WITH ANTI‐CCR4 ANTIBODY MOGAMULIZUMAB FOR ELDERLY PATIENTS WITH CCR4‐POSITIVE ADULT T‐CELL LEUKEMIA/LYMPHOMA","abstract":"Background: No standard of care for elderly patients with aggressive adult T-cell leukemia/lymphoma (ATL) has been established yet. We assessed the efficacy of an anti-CCR4 antibody, mogamulizumab (Moga)combined with biweekly cyclophosphamide (CPA), doxorubicin (DXR), vincristine (VCR), and prednisone (PSL) (Moga-CHOP-14) for untreated elderly patients with aggressive ATL. Methods: In this phase 2 trial conducted at 21 centers in Japan, untreated CCR4-positive aggressive ATL patients aged 66 years or older and 56–65 years who were not candidates for allogeneic hematopoietic stem cell transplantation (allo-HSCT) received six cycles of Moga-CHOP-14, followed by two cycles of Moga monotherapy. The primary endpoint was 1-year progression-free survival (PFS), defined as the time from enrollment to the progression/relapse of ATL or death due to any cause, whichever occurred first. Secondary endpoints were complete response rate (CR), overall response rate (ORR), overall survival (OS), 1-year event-free survival (EFS), and the incidence of adverse events. The necessary number of patients calculated by setting the threshold 1-yearPFS at 16% and the expected 1-year PFS at 31% using the exact method based on binomial distribution under the conditions of one-sided level of significance of 5% (α = 0.05) and power of 70% was 43. Results: A total of 50 patients were enrolled from October 2015, until September 2020. Among the 48 evaluable patients, the median age was74 years (interquartile range [IQR], 70–78). ATL subtypes included 31, 9, and 8 patients for the acute, lymphoma, and unfavorable chronic type, respectively. ATL-PI included 9, 31, and 8 patients for high, intermediate, and low risk, respectively. With a median follow-up of 1.6years (IQR, 0.7–2.4), 1-year PFS was 36.2% (90% confidence interval (CI), 24.9–47.6), and a median PFS was 0.7 years (95% CI, 0.5–1.0).CR and ORR were noted in 64.6% (95% CI, 49.5–77.8), and 91.7%(95% CI, 80.0–97.7), respectively. One-year OS was 66.0% (95% CI, 50.6–77.6) and median OS was 1.6 years (95% CI, 1.1–2.8). One-year EFS was 29.9% (95% CI, 17.6–43.2) and median EFS was 0.5 years (95% CI, 0.4–0.7). The most frequent adverse events grades 3/4, which occurred in >10% of patients were lymphocytopenia (97.9%), leukopenia (93.8%), neutropenia (89.6%), febrile neutropenia (64.8%), anemia (58.3%), thrombocytopenia (45.8%), infection (27.1%), skin rash (20.8%), and hyperglycemia (20.8%). Relative dose intensity (RDI) was calculated for each drug: the mean RDI for Moga was 82.1%, for CPA 71.7%, for DXR 72.7%, for VCR 72.0%, and for PSL 77.3%. Conclusions: This study demonstrated that Moga-CHOP-14 significantly improved PFS in elderly patients with aggressive CCR4-positive ATL who were ineligible for allo-HSCT. Moga-CHOP-14 is now considered for the preferred first-line treatment in those patients. Clinical trial ID:jRCTs041180130. Encore Abstract—previously submitted to ASCO 2023 The research was funded by: Kyowa Kirin and Japan Agency for Medical Research and Development Keyword: combination therapies Conflicts of interests pertinent to the abstract A. Utsunomiya Consultant or advisory role: JIMRO, Otsuka Medical Devices Honoraria: Bristol-Myers Squibb Japan, Meiji Seika Kaisha S. Kusumoto Honoraria: Chugai Pharma, Kyowa Kirin, Daiichi Sankyo Research funding: Chugai Pharma, Kyowa Kirin, Daiichi Sankyo M. Yoshimitsu Consultant or advisory role: Takeda Honoraria: Takeda, Sanofi, Novartis, Daiichi Sankyo K. Nosaka Consultant or advisory role: Kyowa Kirin Honoraria: Meiji Seika, Janssen, Kyowa Kirin, Abbvie, Daiichi Sankyo, Eisai, Bristol-Myers Squibb Japan Research funding: Chugai Pharma, Kyowa Kirin S. Rai Honoraria: Chugai Pharma, Janssen, Ono Pharmaceutical D. Nakamura Honoraria: Sanofi, Takeda, Nippon Shinyaku, Chugai Pharma, Janssen, Abbvie, Meiji Seika K. Ishitsuka Consultant or advisory role: Daiichi Sankyo, Meiji Seika Honoraria: Celgene, Bristol-Myers Squibb Japan, Eisai, Pfizer, Daiichi Sankyo, Tak","journal":"Hematological Oncology","year":2023,"id":408408,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9541,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1187666,"name":"Shigeru Kusumoto","orcid":"0000-0001-6546-1279","position":1,"is_corresponding":false},{"id":1187685,"name":"Ilseung Choi","orcid":"0000-0002-8920-7045","position":2,"is_corresponding":false},{"id":639124,"name":"Makoto Yoshimitsu","orcid":"0000-0002-5935-0385","position":3,"is_corresponding":false},{"id":546062,"name":"Mototsugu Shimokawa","orcid":"0000-0001-8140-4565","position":4,"is_corresponding":false},{"id":1187686,"name":"Yutaka Suehiro","orcid":"0000-0002-8822-0053","position":5,"is_corresponding":false},{"id":639143,"name":"Tomonori Hidaka","orcid":"0000-0002-7018-3653","position":6,"is_corresponding":false},{"id":639125,"name":"Kisato Nosaka","orcid":"0000-0001-6682-2451","position":7,"is_corresponding":false},{"id":849878,"name":"Hiroyuki Sasaki","orcid":"0000-0001-8239-8275","position":8,"is_corresponding":false},{"id":1019642,"name":"Shinya Rai","orcid":"0000-0003-3929-9751","position":9,"is_corresponding":false},{"id":1188097,"name":"S. Tamura","orcid":null,"position":10,"is_corresponding":false},{"id":1188098,"name":"Satsuki Owatari","orcid":null,"position":11,"is_corresponding":false},{"id":1188099,"name":"K. Koh","orcid":null,"position":12,"is_corresponding":false},{"id":639146,"name":"Michihiro Hidaka","orcid":"0000-0002-8645-2184","position":13,"is_corresponding":false},{"id":402553,"name":"Tomoaki Kato","orcid":"0000-0002-4593-4857","position":14,"is_corresponding":false},{"id":1187687,"name":"Tatsuro Jo","orcid":"0000-0001-5415-6228","position":15,"is_corresponding":false},{"id":1188100,"name":"Yukiyoshi Moriuchi","orcid":null,"position":16,"is_corresponding":false},{"id":1187688,"name":"Masao Ogata","orcid":"0000-0002-4896-5878","position":17,"is_corresponding":false},{"id":1188087,"name":"Eiichi Ohtsuka","orcid":null,"position":18,"is_corresponding":false},{"id":1188101,"name":"Hitoshi Suzushima","orcid":null,"position":19,"is_corresponding":false},{"id":1187689,"name":"Shigeki Ito","orcid":"0000-0002-3899-6603","position":20,"is_corresponding":false},{"id":1187690,"name":"Shinichiro Yoshida","orcid":"0000-0003-0590-559X","position":21,"is_corresponding":false},{"id":1187691,"name":"Asahi Ito","orcid":"0000-0001-8082-8008","position":22,"is_corresponding":false},{"id":1187692,"name":"Daisuke Nakamura","orcid":"0000-0002-5280-9392","position":23,"is_corresponding":false},{"id":1187693,"name":"Masahito Tokunaga","orcid":"0000-0003-1296-9006","position":24,"is_corresponding":false},{"id":639141,"name":"Masaaki Sekine","orcid":"0000-0001-5481-3451","position":25,"is_corresponding":false},{"id":250930,"name":"Yuma Sakamoto","orcid":"0000-0001-9916-4862","position":26,"is_corresponding":false},{"id":1187694,"name":"Hiroshi Inagaki","orcid":"0000-0001-6157-636X","position":27,"is_corresponding":false},{"id":1142221,"name":"Takashi Ishida","orcid":"0000-0002-1060-0777","position":28,"is_corresponding":false},{"id":639153,"name":"Kenji Ishitsuka","orcid":"0000-0002-7030-497X","position":29,"is_corresponding":false},{"id":639148,"name":"Atae Utsunomiya","orcid":"0000-0002-8843-406X","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-19T01:21:18.414003Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}