Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study
Background: Epigenetic priming prior to chemotherapy represents a promising treatment strategy for refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL). We conducted a phase II trial to evaluate the efficacy and safety of azacitidine in combination with R-GDP (rituximab/gemcitabine/dexam...
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SAGE Publishing
2025-07-01
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| Series: | Therapeutic Advances in Hematology |
| Online Access: | https://doi.org/10.1177/20406207251349361 |
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| _version_ | 1849427661439369216 |
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| author | Dong Hyun Kim Jee Hyun Kong Junshik Hong Ja Min Byun Dong-Yeop Shin Youngil Koh Inho Kim Jinny Park Young Rok Do Jeong-A Kim Won Seog Kim Ho-Jin Shin Sung-Soo Yoon |
| author_facet | Dong Hyun Kim Jee Hyun Kong Junshik Hong Ja Min Byun Dong-Yeop Shin Youngil Koh Inho Kim Jinny Park Young Rok Do Jeong-A Kim Won Seog Kim Ho-Jin Shin Sung-Soo Yoon |
| author_sort | Dong Hyun Kim |
| collection | DOAJ |
| description | Background: Epigenetic priming prior to chemotherapy represents a promising treatment strategy for refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL). We conducted a phase II trial to evaluate the efficacy and safety of azacitidine in combination with R-GDP (rituximab/gemcitabine/dexamethasone/cisplatin) in transplant-ineligible R/R DLBCL. Methods: Fifteen patients were enrolled and treated with azacitidine and R-GDP regimen (NCT03719989). Azacitidine was administered intravenously at a dose of 25 mg/m 2 /day for 5 days. Each cycle consisted of 21 days, with patients receiving up to a maximum of six cycles. The primary endpoint was the objective response rate, and the secondary objectives were toxicity, progression-free survival (PFS), and overall survival (OS). Results: Overall, 15 patients were enrolled in the study from March 2019 to August 2023, and the median age was 64 years (range: 41–75). The objective response rate was 66.7% with a complete response rate of 53.3%. The most common grade 3 or higher adverse events were hematologic toxicities, including neutropenia (66.7%) and thrombocytopenia (53.3%). Grade 3 or higher non-hematologic toxicities were rare, and most adverse events were transient and manageable. During a median follow-up of 15.8 months, five patients died, all from DLBCL. The median PFS was 12.6 months, while the median OS was not reached. Conclusion: Our study suggests that azacitidine followed by R-GDP is an effective and safe strategy for transplant-ineligible patients with R/R DLBCL. This represents the first phase II study to demonstrate the potential of epigenetic priming with azacitidine to enhance chemosensitivity in this patient population. Trial registration: ClinicalTrials.gov identifier: NCT03719989. |
| format | Article |
| id | doaj-art-7ef96f920aeb4fadad6f22f46ac7c818 |
| institution | Kabale University |
| issn | 2040-6215 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Hematology |
| spelling | doaj-art-7ef96f920aeb4fadad6f22f46ac7c8182025-08-20T03:28:58ZengSAGE PublishingTherapeutic Advances in Hematology2040-62152025-07-011610.1177/20406207251349361Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II studyDong Hyun KimJee Hyun KongJunshik HongJa Min ByunDong-Yeop ShinYoungil KohInho KimJinny ParkYoung Rok DoJeong-A KimWon Seog KimHo-Jin ShinSung-Soo YoonBackground: Epigenetic priming prior to chemotherapy represents a promising treatment strategy for refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL). We conducted a phase II trial to evaluate the efficacy and safety of azacitidine in combination with R-GDP (rituximab/gemcitabine/dexamethasone/cisplatin) in transplant-ineligible R/R DLBCL. Methods: Fifteen patients were enrolled and treated with azacitidine and R-GDP regimen (NCT03719989). Azacitidine was administered intravenously at a dose of 25 mg/m 2 /day for 5 days. Each cycle consisted of 21 days, with patients receiving up to a maximum of six cycles. The primary endpoint was the objective response rate, and the secondary objectives were toxicity, progression-free survival (PFS), and overall survival (OS). Results: Overall, 15 patients were enrolled in the study from March 2019 to August 2023, and the median age was 64 years (range: 41–75). The objective response rate was 66.7% with a complete response rate of 53.3%. The most common grade 3 or higher adverse events were hematologic toxicities, including neutropenia (66.7%) and thrombocytopenia (53.3%). Grade 3 or higher non-hematologic toxicities were rare, and most adverse events were transient and manageable. During a median follow-up of 15.8 months, five patients died, all from DLBCL. The median PFS was 12.6 months, while the median OS was not reached. Conclusion: Our study suggests that azacitidine followed by R-GDP is an effective and safe strategy for transplant-ineligible patients with R/R DLBCL. This represents the first phase II study to demonstrate the potential of epigenetic priming with azacitidine to enhance chemosensitivity in this patient population. Trial registration: ClinicalTrials.gov identifier: NCT03719989.https://doi.org/10.1177/20406207251349361 |
| spellingShingle | Dong Hyun Kim Jee Hyun Kong Junshik Hong Ja Min Byun Dong-Yeop Shin Youngil Koh Inho Kim Jinny Park Young Rok Do Jeong-A Kim Won Seog Kim Ho-Jin Shin Sung-Soo Yoon Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study Therapeutic Advances in Hematology |
| title | Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study |
| title_full | Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study |
| title_fullStr | Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study |
| title_full_unstemmed | Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study |
| title_short | Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study |
| title_sort | azacitidine followed by r gdp in transplant ineligible relapsed refractory diffuse large b cell lymphoma preliminary results from a multicenter phase ii study |
| url | https://doi.org/10.1177/20406207251349361 |
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