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1629 The ZR2-Minichop Study:Zanubrutinib, Lenalidomide, Rituximab, Cyclophosphamide, Vincristine, Epirubicin and Prednisone in Elderly Patients with Previously Untreated Diffuse Large B-Cell Lymphoma

Program: Oral and Poster Abstracts
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Hematology Disease Topics & Pathways:
Research, clinical trials, Biological therapies, Lymphomas, non-Hodgkin lymphoma, Non-Biological therapies, elderly, Clinical Research, B Cell lymphoma, Chemotherapy, Combination therapy, Diseases, drug-drug interactions, Therapies, Immunotherapy, Lymphoid Malignancies, Study Population, Human
Saturday, December 10, 2022, 5:30 PM-7:30 PM

Jianai Sun1,2*, Yi Xu2*, Min Yang, M.D.1,3*, Huafeng Wang1,2*, Wenjuan Yu, MD3*, Liangshun You1,2*, Haitao Meng1,2*, Chunmei Yang1,3*, Xinping Zhou1,2*, Li Li1,2*, De Zhou, MD1,2*, Xiujing Ye1,2*, Hong-hu Zhu, M.D., Ph.D.1,2*, Hongyan Tong1,2*, Jie Jin, M.D., Ph.D.1,2 and Wanzhuo Xie1,3*

1Zhejiang Provincial Key Laboratory of Hematopoietic Malignancy, Zhejiang University, Hangzhou, Zhejiang, PR China, Hangzhou, China
2Department of Hematology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, PR China, Hangzhou, China
3Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

Background: Diffuse large B cell lymphoma (DLBCL) is common in the elderly group. New schedules are required due to the toxicity in classic chemotherapy regimens. Previous studies reported that non-germinal center B cell (non-GCB) subtype aggregates in elderly patients with abnormality in the activated B cell receptor signal and nuclear factor kappa-B pathway. We conducted a prospective trial to investigate the efficacy and safety of the ZR2-miniCHOP schedule (zanubrutinib, lenalidomide, rituximab, cyclophosphamide, vincristine, epirubicin and prednisone) in elder patients newly diagnosed with non-GCB DLBCL.

Methods: This multicenter, single-arm, phase II clinical study started in June 2021 at 6 centers in China. Eligible patients were newly diagnosed non-GCB DLBCL, aged 60 to 80 with Eastern Cooperation Oncology Group (ECOG) performance status over 2, or patients aged over 80 with ECOG status of 0-4. The purpose of this study is to discuss the response, safety and long-term survival with the primary endpoint of objective response rate (ORR) and the secondary endpoint of overall survival (OS) and progression free survival (PFS). Patients would receive 2 cycles induction period with zanubrutinib 160mg twice per day on d1-28, lenalidomide 25mg d1-10 and rituximab 375mg/m2 d1, after then combine 4-6 cycles miniCHOP schedule as: cyclophosphamide 400mg/m2 d2, vincristine 1.4mg/m2 d2, epirubicin 35mg/m2 d2 and prednisone 45mg/m2 d2-6. Evaluation is conducted after 6 cycles of treatment including the ORR and CR rate by positron emission tomography-computed tomography (PET-CT) and 2-years OS and PFS.

Results: At the data collection duration from June 2021 to June 2022, 26 patients were recruited in this trial. 16 patients were considered for result analysis as 2 withdrawals and 1 drop-out. 7 patients are still in the process of treatment. The median age of the 26 patients enrolled was 77 (range 65-90) years, with 17 patients over 75 years old. The ORR was 93.8% (15/16). The CR rate was 62.5% (10/16). The most common hematology-relevant adverse events (AEs) were neutropenia (7/26) and thrombocytopenia (4/26). Seven AEs over grade 3 occurred during therapy with 3 neutropenia events and 4 thrombocytopenia events. All these patients have administrated the normal dose as the treatment resistance and the toxicity did not affect therapy. One patient died of progressive disease. No treatment-associated death was observed. Generally analyzing, this trial achieved acceptable response and safety.

Conclusion: The ZR2-miniCHOP schedule represented satisfactory efficacy and safety in elderly non-GCB DLBCL.

Disclosures: Jin: Suzhou Zelgen Biopharmaceuticals Co.,Ltd.: Honoraria.

*signifies non-member of ASH