Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in context
Summary: Background: Outcomes of older patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem-cell transplantation (allo-HSCT) remain unsatisfactory. The primary objective of this trial was to establish whether decitabine combined with reduced-intensity conditioning (RI...
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2025-08-01
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| Series: | The Lancet Regional Health. Western Pacific |
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| author | Qifa Liu Zhongli Hu Na Xu Yirong Jiang Zhiping Fan Fen Huang Ren Lin Hua Jin Yunxin Zeng Hai He Ping Zhu Guopan Yu Pengcheng Shi Ruijuan Sun Xiaojun Xu Zhangkun Li Yu Zhang Jing Sun Yu Wang Li Xuan |
| author_facet | Qifa Liu Zhongli Hu Na Xu Yirong Jiang Zhiping Fan Fen Huang Ren Lin Hua Jin Yunxin Zeng Hai He Ping Zhu Guopan Yu Pengcheng Shi Ruijuan Sun Xiaojun Xu Zhangkun Li Yu Zhang Jing Sun Yu Wang Li Xuan |
| author_sort | Qifa Liu |
| collection | DOAJ |
| description | Summary: Background: Outcomes of older patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem-cell transplantation (allo-HSCT) remain unsatisfactory. The primary objective of this trial was to establish whether decitabine combined with reduced-intensity conditioning (RIC) regimen could improve overall survival (OS) for this population in composite complete remission (CRc). Methods: We conducted a single-arm, phase 2 trial at six hospitals in China. Eligible patients were aged 60–80 years, had a diagnosis of AML, achieved CRc at transplantation, were willing to undergo the first allo-HSCT, and had an Eastern Cooperative Oncology Group performance status of 0–2. Patients received decitabine combined with RIC regimen, comprising decitabine 20 mg/m2 daily intravenously (days −9 to −7), busulfan 3.2 mg/kg daily intravenously (days −5 to −4), and fludarabine 30 mg/m2 daily intravenously (days −6 to −3). The primary endpoint was 2-year OS rate. All efficacy and safety endpoints were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT03530085) and is complete. Findings: Between Jan 1, 2021 and Nov 30, 2022, 60 patients were enrolled. With a median follow-up of 35.5 months (IQR 32.5–39.2), 39 patients survived and 21 died. The 2-year OS rate was 67% (95% CI 56–80), which met the primary objective. Within 100 days post-transplantation, the most common grade 3–4 non-hematological treatment-emergent adverse events (TEAEs) were infections (22 [37%]), acute graft-versus-host disease (21 [35%]), and gastrointestinal disorders (16 [27%]). Five (8%) patients died of TEAEs, with one death treatment-related. Interpretation: Decitabine combined with RIC regimen exhibits encouraging OS and acceptable toxicity profile, which might be a suitable therapeutic option for older patients with AML. Funding: National Natural Science Foundation of China; Science and Technology Program of Guangdong Province; National Key Research and Development Program of China. |
| format | Article |
| id | doaj-art-361c8aa7afff450a86b1ff82dd8ab0d7 |
| institution | Kabale University |
| issn | 2666-6065 |
| language | English |
| publishDate | 2025-08-01 |
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| series | The Lancet Regional Health. Western Pacific |
| spelling | doaj-art-361c8aa7afff450a86b1ff82dd8ab0d72025-08-20T03:41:57ZengElsevierThe Lancet Regional Health. Western Pacific2666-60652025-08-016110166410.1016/j.lanwpc.2025.101664Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in contextQifa Liu0Zhongli Hu1Na Xu2Yirong Jiang3Zhiping Fan4Fen Huang5Ren Lin6Hua Jin7Yunxin Zeng8Hai He9Ping Zhu10Guopan Yu11Pengcheng Shi12Ruijuan Sun13Xiaojun Xu14Zhangkun Li15Yu Zhang16Jing Sun17Yu Wang18Li Xuan19Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Department of Bone Marrow Transplantation, Hebei Yanda Lu Daopei Hospital, Langfang, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Affiliated Dongguan People’s Hospital, Southern Medical University (Dongguan People’s Hospital), Dongguan, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, the Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen, ChinaDepartment of Bone Marrow Transplantation, Hebei Yanda Lu Daopei Hospital, Langfang, ChinaDepartment of Hematology, the First People Hospital of Chenzhou, Chenzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Bone Marrow Transplantation, Hebei Yanda Lu Daopei Hospital, Langfang, ChinaDepartment of Hematology, the Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen, ChinaDepartment of Hematology, Affiliated Dongguan People’s Hospital, Southern Medical University (Dongguan People’s Hospital), Dongguan, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, ChinaDepartment of Hematology, Peking University People’s Hospital, Beijing, ChinaDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Clinical Medical Research Center of Hematology Diseases of Guangdong Province, Guangzhou, China; Corresponding author. Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.Summary: Background: Outcomes of older patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem-cell transplantation (allo-HSCT) remain unsatisfactory. The primary objective of this trial was to establish whether decitabine combined with reduced-intensity conditioning (RIC) regimen could improve overall survival (OS) for this population in composite complete remission (CRc). Methods: We conducted a single-arm, phase 2 trial at six hospitals in China. Eligible patients were aged 60–80 years, had a diagnosis of AML, achieved CRc at transplantation, were willing to undergo the first allo-HSCT, and had an Eastern Cooperative Oncology Group performance status of 0–2. Patients received decitabine combined with RIC regimen, comprising decitabine 20 mg/m2 daily intravenously (days −9 to −7), busulfan 3.2 mg/kg daily intravenously (days −5 to −4), and fludarabine 30 mg/m2 daily intravenously (days −6 to −3). The primary endpoint was 2-year OS rate. All efficacy and safety endpoints were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT03530085) and is complete. Findings: Between Jan 1, 2021 and Nov 30, 2022, 60 patients were enrolled. With a median follow-up of 35.5 months (IQR 32.5–39.2), 39 patients survived and 21 died. The 2-year OS rate was 67% (95% CI 56–80), which met the primary objective. Within 100 days post-transplantation, the most common grade 3–4 non-hematological treatment-emergent adverse events (TEAEs) were infections (22 [37%]), acute graft-versus-host disease (21 [35%]), and gastrointestinal disorders (16 [27%]). Five (8%) patients died of TEAEs, with one death treatment-related. Interpretation: Decitabine combined with RIC regimen exhibits encouraging OS and acceptable toxicity profile, which might be a suitable therapeutic option for older patients with AML. Funding: National Natural Science Foundation of China; Science and Technology Program of Guangdong Province; National Key Research and Development Program of China.http://www.sciencedirect.com/science/article/pii/S2666606525002032DecitabineReduced-intensity conditioningOlderAcute myeloid leukemiaAllogeneic hematopoietic stem cell transplantation |
| spellingShingle | Qifa Liu Zhongli Hu Na Xu Yirong Jiang Zhiping Fan Fen Huang Ren Lin Hua Jin Yunxin Zeng Hai He Ping Zhu Guopan Yu Pengcheng Shi Ruijuan Sun Xiaojun Xu Zhangkun Li Yu Zhang Jing Sun Yu Wang Li Xuan Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in context The Lancet Regional Health. Western Pacific Decitabine Reduced-intensity conditioning Older Acute myeloid leukemia Allogeneic hematopoietic stem cell transplantation |
| title | Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in context |
| title_full | Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in context |
| title_fullStr | Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in context |
| title_full_unstemmed | Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in context |
| title_short | Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trialResearch in context |
| title_sort | decitabine combined with reduced intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation a multicenter single arm phase 2 trialresearch in context |
| topic | Decitabine Reduced-intensity conditioning Older Acute myeloid leukemia Allogeneic hematopoietic stem cell transplantation |
| url | http://www.sciencedirect.com/science/article/pii/S2666606525002032 |
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