PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial
Abstract Background This investigation assessed the therapeutic potential of combining linperlisib, a targeted inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), with gemcitabine and oxaliplatin (GEMOX) for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Meth...
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BMC
2025-02-01
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| Online Access: | https://doi.org/10.1186/s12935-025-03669-2 |
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| author | Peng Sun Hong Cen Haiyan Yang Rui Huang Zhen Cai Xuekui Gu Hanying Bao Zusheng Xu Zuhong Xu Zhi-Ming Li |
| author_facet | Peng Sun Hong Cen Haiyan Yang Rui Huang Zhen Cai Xuekui Gu Hanying Bao Zusheng Xu Zuhong Xu Zhi-Ming Li |
| author_sort | Peng Sun |
| collection | DOAJ |
| description | Abstract Background This investigation assessed the therapeutic potential of combining linperlisib, a targeted inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), with gemcitabine and oxaliplatin (GEMOX) for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Methods This was a multicenter, phase Ib/II clinical study conducted across six sites in China, enrolling 39 individuals with histologically confirmed R/R DLBCL. The treatment protocol included oral linperlisib alongside GEMOX administered intravenously every three weeks for up to six cycles. The primary efficacy endpoint was the objective response rate (ORR). Results The ORR observed in the full study population was 53.8% (95% confidence interval [CI]: 37.2–69.9). The median duration of response was 5.7 months (95% CI: 4.3–9.1), and the median progression-free survival was 5.4 months (95% CI: 1.8–6.7). The 1-year OS rate was 65.5% (95% CI: 48.1–78.3). Frequently observed adverse events included decreases in neutrophil counts (74.4%), white blood cell counts (64.1%) and platelet counts (64.1%). Conclusions This study highlights the potential of linperlisib plus GEMOX as a treatment for R/R DLBCL, demonstrating a tolerable safety profile and encouraging efficacy results. Trial registration NCT04500561. |
| format | Article |
| id | doaj-art-cb38c3f38a8b483d83a3a033defcbd85 |
| institution | Kabale University |
| issn | 1475-2867 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
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| series | Cancer Cell International |
| spelling | doaj-art-cb38c3f38a8b483d83a3a033defcbd852025-02-09T12:55:25ZengBMCCancer Cell International1475-28672025-02-012511910.1186/s12935-025-03669-2PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trialPeng Sun0Hong Cen1Haiyan Yang2Rui Huang3Zhen Cai4Xuekui Gu5Hanying Bao6Zusheng Xu7Zuhong Xu8Zhi-Ming Li9Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterDepartment of Lymphohematology and Pediatric Oncology, Guangxi Medical University Affiliated Tumor HospitalDepartment of Lymphoma, Zhejiang Cancer HospitalDepartment of Hematology, Zhujiang Hospital of Southern Medical UniversityBone Marrow Transplantation Center of Hematology Department, The First Affiliated Hospital of Zhejiang University School of MedicineDepartment of Hematology, The First Affiliated Hospital of Guangzhou University of Traditional Chinese MedicineClinical Development Department, Shanghai Yingli Pharmaceutical Co., LtdClinical Development Department, Shanghai Yingli Pharmaceutical Co., LtdClinical Development Department, Shanghai Yingli Pharmaceutical Co., LtdDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer CenterAbstract Background This investigation assessed the therapeutic potential of combining linperlisib, a targeted inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), with gemcitabine and oxaliplatin (GEMOX) for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Methods This was a multicenter, phase Ib/II clinical study conducted across six sites in China, enrolling 39 individuals with histologically confirmed R/R DLBCL. The treatment protocol included oral linperlisib alongside GEMOX administered intravenously every three weeks for up to six cycles. The primary efficacy endpoint was the objective response rate (ORR). Results The ORR observed in the full study population was 53.8% (95% confidence interval [CI]: 37.2–69.9). The median duration of response was 5.7 months (95% CI: 4.3–9.1), and the median progression-free survival was 5.4 months (95% CI: 1.8–6.7). The 1-year OS rate was 65.5% (95% CI: 48.1–78.3). Frequently observed adverse events included decreases in neutrophil counts (74.4%), white blood cell counts (64.1%) and platelet counts (64.1%). Conclusions This study highlights the potential of linperlisib plus GEMOX as a treatment for R/R DLBCL, demonstrating a tolerable safety profile and encouraging efficacy results. Trial registration NCT04500561.https://doi.org/10.1186/s12935-025-03669-2LinperlisibGemcitabineOxaliplatinPI3Kδ-selective inhibitorDiffuse large B-cell lymphoma |
| spellingShingle | Peng Sun Hong Cen Haiyan Yang Rui Huang Zhen Cai Xuekui Gu Hanying Bao Zusheng Xu Zuhong Xu Zhi-Ming Li PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial Cancer Cell International Linperlisib Gemcitabine Oxaliplatin PI3Kδ-selective inhibitor Diffuse large B-cell lymphoma |
| title | PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial |
| title_full | PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial |
| title_fullStr | PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial |
| title_full_unstemmed | PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial |
| title_short | PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial |
| title_sort | pi3kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large b cell lymphoma a multicenter single arm phase ib ii trial |
| topic | Linperlisib Gemcitabine Oxaliplatin PI3Kδ-selective inhibitor Diffuse large B-cell lymphoma |
| url | https://doi.org/10.1186/s12935-025-03669-2 |
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