Polatuzumab vedotin plus R-CHP therapy in patients with previously untreated diffuse large B-cell lymphoma

Conditions

Diffuse large B-cell lymphom DLBCL

Kumode T, Sawa H, Miyawaki K, Satake A, Kanemura N, Suzuki R, Fujiwara Y, Nagate Y, Ota S, Fujino T, Goto H, Fukuhara N, Sakata-Yanagimoto M, Izutsu K, Nishikori M, Shibayama H, Ennishi D, Shimose T, Asai M, Matsumura I, Akashi K, Kato K.

2026-07-24

10.1111/cas.70484

Preliminary analysis of a multicenter study of Pola-R-CHP in untreated Japanese patients with DLBCL (POLASTAR).

Satake A, Nagate Y, Miyawaki K, Fujiwara Y, Ota S, Muta T, Rai S, Tsurumi H, Suzuki R, Miyake T, Goto H, Fukuhara N, Sakata-Yanagimoto M, Izutsu K, Nishikori M, Shibayama H, Kumode T, Ennishi D, Shimose T, Inubashiri N, Matsumura I, Akashi K, Kato K.

2025-12-03

10.1007/s12185-025-04122-w

A Multicenter, Prospective, Observational Study of Pola-R-CHP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (POLASTAR): A Preliminary Analysis

Hirohiko Shibayama, Atsushi Satake, Kohta Miyawaki, Yuki Fujiwara, Shuichi Ota et al. (22 authors)

Blood2024-11-052 citations

10.1182/blood-2024-192949

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with previously untreated diffuse large B-cell lymphoma 2. Patients who are scheduled to undergo polatuzumab vedotin (Pola) plus R-CHP therapy as medical practice based on the latest package insert of Pola 3. Patients who have received a sufficient explanation about the content of this study, have provided voluntary written informed consent from themselves, and are able to comply with the requirements of the study protocol 4. Patients aged 18 years or older at the time of obtaining informed consent

Exclusion criteria

Exclusion criteria: Patients judged inappropriate for participation in this study by the site-investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
1)Progression free survival (PFS) 2)Two years progression free survival (PFS24) 3)Central nervous system (CNS) recurrence rate 4)Time to CNS recurrence 5)Best overall response (BOR) 6)Complete response rate at the end of treatment (EOT-CRR) 7)Overall response rate at the end of treatment (EOT-ORR) 8)Duration of response (DOR) 9)Safety 10)Relationship between patient background/ baseline characteristics and efficacy/safety 11)Relationship between geriatric assessment (G8) and efficacy/safety 12)Correlation between relative dose intensity and efficacy/safety	—

Measure

Time frame

1)Progression free survival (PFS) 2)Two years progression free survival (PFS24) 3)Central nervous system (CNS) recurrence rate 4)Time to CNS recurrence 5)Best overall response (BOR) 6)Complete response rate at the end of treatment (EOT-CRR) 7)Overall response rate at the end of treatment (EOT-ORR) 8)Duration of response (DOR) 9)Safety 10)Relationship between patient background/ baseline characteristics and efficacy/safety 11)Relationship between geriatric assessment (G8) and efficacy/safety 12)Correlation between relative dose intensity and efficacy/safety

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Contacts

Public ContactKoji Kato

Kyushu University Hospital

kato.koji.429@m.kyushu-u.ac.jp+81-92-642-5230

Outcome results