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更新于：2026-10-23
Clofarabine
氯法拉滨
更新于：2026-10-23
概要
基本信息
药物类型 小分子化药 |
别名 (2R,3R,4S,5R)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol、2-chloro-9-(2'-deoxy-2'-fluoro-β-D-arabinofuranosyl)adenine、2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)adenine + [18] |
作用方式 抑制剂、刺激剂 |
作用机制 POLA1抑制剂(DNA聚合酶α亚基抑制剂)、RNR抑制剂(核糖核苷酸还原酶复合体抑制剂)、细胞凋亡刺激剂 |
非在研适应症 |
原研机构 |
在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2004-12-28), |
最高研发阶段(中国)临床3期 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、孤儿药 (韩国) |
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结构/序列
分子式C10H11ClFN5O3 |
InChIKeyWDDPHFBMKLOVOX-AYQXTPAHSA-N |
CAS号123318-82-1 |
关联
191
项与 氯法拉滨 相关的临床试验NCT07644481
Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission: An Open-Label, Prospective, Single-Arm Clinical Trial
CTR20250067
在中国患者中评价氯法拉滨注射液的多中心、前瞻性、观察性、真实世界研究
NCT07566377
Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies
100 项与 氯法拉滨 相关的临床结果
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100 项与 氯法拉滨 相关的转化医学
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100 项与 氯法拉滨 相关的专利（医药）
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903
项与 氯法拉滨 相关的文献（医药）2026-08-01INTERNATIONAL JOURNAL OF HEMATOLOGY
Safety and efficacy of clofarabine for preconditioning intervention in patients undergoing allogeneic hematopoietic stem cell transplantation for relapsed/refractory acute lymphoblastic leukemia
Article
作者: Abe, Maasa ; Miyazaki, Takuya ; Yamazaki, Etsuko ; Izumi, Akihiko ; Konishi, Hiroaki ; Takeda, Takaaki ; Sato, Shuku ; Bando, Kana ; Tanaka, Masatsugu ; Nakajima, Hideaki ; Tachibana, Takayoshi ; Suzuki, Takahiro ; Uemura, Yu ; Suzuki, Taisei
Previous studies have suggested that intensive chemotherapy to induce bone marrow hypoplasia before allogeneic hematopoietic stem cell transplantation (HSCT) may improve outcomes in relapsed/refractory acute lymphoblastic leukemia. In this retrospective single-center study, we analyzed 14 patients who received clofarabine (CLO) as a preconditioning intervention (PCI) before HSCT between 2019 and 2024. PCI was defined as initiation of conditioning within 2 weeks after CLO. The median age was 34 years, and seven patients were not in remission at the time of CLO. CLO (30 mg/m2 for 5 days) was given in one or two cycles. WBC and bone marrow nucleated cells significantly decreased after CLO. The 1-year overall survival, relapse incidence, and non-relapse mortality rates were 67.5%, 32.2%, and 21.6%, respectively. Neutrophil engraftment was achieved in all patients. Acute and chronic graft-versus-host disease occurred in four and two patients, respectively. Bloodstream infections within 100 days after HSCT were observed in nine patients. Thrombotic microangiopathy (n = 2), sinusoidal obstruction syndrome/veno-occlusive disease (n = 2), drug-induced cardiomyopathy (n = 1), and organizing pneumonia (n = 1) were also observed but were clinically manageable. Considering the high-risk nature of this cohort, CLO-based PCI followed by HSCT appears to be a feasible treatment strategy with acceptable toxicity, warranting further investigation.
2026-07-01Acta Crystallographica Section E-Crystallographic Communications
Crystal structure of clofarabine (form I), C
10
H
11
ClFN
5
O
3
, from synchrotron power diffraction data and density functional theory calculations
Article
作者: Blanton, Thomas N ; Salazar, Jacob K ; Dosen, Anja ; Kaduk, James A
The crystal structure of clofarabine (form I) [systematic name: 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9
H
-purin-6-amine], C
10
H
11
ClFN
5
O
3
, has been solved and refined using synchrotron X-ray powder diffraction data, and optimized using density functional theory techniques. The oxolane ring adopts an envelope conformation and the angle between the mean ring planes is 88.4 (2)°, resulting in an L-shaped molecule. The molecules stack along the short
a
-axis direction, and N—H...O, O—H...N and N—H...N hydrogen bonds link them into a three-dimensional network.
2026-05-01Blood neoplasia
Survival after intensive therapy or clofarabine in fit older adults with acute myeloid leukemia: E2906 phase 3 trial
Article
作者: Pratz, Keith W ; Paietta, Elisabeth ; Tallman, Martin S ; Zhang, Yanming ; Racevskis, Janis ; Rowe, Jacob M ; Lazarus, Hillard M ; Ofran, Yishai ; Arber, Daniel A ; Litzow, Mark R ; Garrett-Bakelman, Fran ; Claxton, David F ; Luger, Selina M ; Broun, E Randolph ; Foran, James M ; Zheng, Hong ; Al-Kali, Aref ; Sun, Zhuoxin ; Powell, Bayard L ; Altman, Jessica K ; Godwin, John E ; O'Dwyer, Kristen Marie
Clofarabine is a second-generation purine nucleoside analog with encouraging reported 30-day induction mortality (IM) and complete remission (CR) or CRi (incomplete platelet recovery) rates, and represents a lower-intensity therapy for older adults with acute myeloid leukemia (AML). We evaluated long-term outcomes in a prospective phase 3 study using a noninferiority design. Patients aged ≥60 years with newly diagnosed AML and normal renal and cardiac function were randomized to standard intensive daunorubicin and cytarabine or single-agent clofarabine. The primary objective was overall survival (OS) using a weighted analysis. We incorporated prospective central testing for measurable residual disease (MRD; ≥0.1%) at remission using multiparameter flow cytometry. Among 727 patients (standard, n = 363; clofarabine, n = 364), there was no difference in CR/CRi (50%) or IM (8.5%) rates. The median follow-up was 58.6 months. In the primary analysis, OS was inferior with clofarabine (median, 10.4 vs 12.4 months [standard]; P = .04), although not in patients aged ≥70 years, with secondary AML, or unfavorable cytogenetics. Allogeneic transplantation was strongly associated with OS on multivariate analysis (HR, 0.53; P < .0001). MRD-negative remission was achieved in 41% of patients and strongly associated with 5-year OS irrespective of treatment (MRD-positive, 48.8% vs 12.2%; P = .003). In contrast, MRD-positive patients assigned to clofarabine (vs high-dose cytarabine) consolidation had significantly inferior OS. Clofarabine is inferior to standard intensive therapy despite similar remission rates. Achieving MRD-negative remission is associated with high, sustained rates of OS regardless of therapy. Increasing MRD negativity and improving outcomes among MRD-positive patients remain pressing, ongoing challenges. This trial was registered at www.clinicaltrials.gov as NCT02085408.
100 项与 氯法拉滨 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 急性淋巴细胞白血病 | 美国 | 2004-12-28 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 移植相关的疾病 | 临床3期 | 美国 | 2011-11-02 | |
| 感染 | 临床3期 | 美国 | 2011-11-02 | |
| 骨髓增生异常综合征 | 临床3期 | 美国 | 2011-11-02 | |
| 急性巨核细胞白血病 | 临床3期 | 美国 | 2008-08-04 | |
| 急性巨核细胞白血病 | 临床3期 | 新加坡 | 2008-08-04 | |
| 核心结合因子急性髓系白血病 | 临床3期 | 美国 | 2008-08-04 | |
| 核心结合因子急性髓系白血病 | 临床3期 | 新加坡 | 2008-08-04 | |
| 急性髓性白血病 | 临床3期 | 加拿大 | 2006-08-01 | |
| 急性髓性白血病 | 临床3期 | 法国 | 2006-08-01 | |
| 急性髓性白血病 | 临床3期 | 德国 | 2006-08-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 727 | 鹽製構顧膚願夢觸網鹽(餘顧蓋鏇廠鹽遞簾艱淵) = 遞簾淵淵觸襯膚廠製製 餘築遞選膚蓋膚顧壓積 (願顧積廠壓鬱鑰蓋鹹築 ) 更多 | 不佳 | 2026-05-01 | |||
鹽製構顧膚願夢觸網鹽(餘顧蓋鏇廠鹽遞簾艱淵) = 簾壓遞襯壓廠醖簾蓋鹽 餘築遞選膚蓋膚顧壓積 (願顧積廠壓鬱鑰蓋鹹築 ) 更多 | |||||||
N/A | 82 | ClofCy | 繭顧鬱鬱窪觸壓觸積願(繭構繭壓憲鏇醖餘獵製) = grade 1, n=13 蓋夢積衊鑰艱獵鏇醖顧 (觸構願齋遞醖鏇憲膚餘 ) 更多 | - | 2025-05-14 | ||
临床2期 | 9 | (Radiation, Thiotepa & Cyclophosphamide) | 繭夢願鏇齋廠製夢繭淵 = 遞願選艱遞糧鹽簾艱遞 鹽築鹹鹹蓋選壓網艱顧 (夢遞壓夢憲製範醖夢遞, 衊糧鏇衊構衊築衊夢積 ~ 選淵鬱繭憲鏇願遞糧鹽) 更多 | - | 2025-04-06 | ||
(Busulfan, Fludarabine & Melphalan) | 繭夢願鏇齋廠製夢繭淵 = 願築願遞簾齋餘廠衊蓋 鹽築鹹鹹蓋選壓網艱顧 (夢遞壓夢憲製範醖夢遞, 窪選鏇夢夢醖鏇襯鹽壓 ~ 衊廠簾齋憲鬱網鑰觸廠) 更多 | ||||||
N/A | 454 | 鏇齋鬱鏇艱願觸積壓築(遞繭鏇積鬱選衊膚顧製) = 範鏇網選淵鑰願遞糧糧 鏇齋簾獵觸壓範獵鏇夢 (簾鑰衊襯繭鏇醖鹽餘廠 ) 更多 | 不佳 | 2025-03-30 | |||
FLAG-IDA | 選網構廠夢獵憲觸遞構(製製淵齋選窪鬱選築製) = 積醖蓋繭願淵觸選築觸 構觸製淵觸廠壓鬱憲廠 (網觸餘醖築觸鹹繭構淵 ) 更多 | ||||||
N/A | - | Clofarabine/busulfan RIC regimen | 積遞製簾築觸夢廠積築(鹽觸襯蓋襯繭構鬱夢鹽) = 鬱顧觸積範醖鏇鏇鹽積 鑰顧顧壓鏇壓範鑰簾壓 (衊遞夢築壓衊鹽簾繭簾 ) 更多 | - | 2024-12-09 | ||
Clofarabine/treosulfan RIC regimen | 積遞製簾築觸夢廠積築(鹽觸襯蓋襯繭構鬱夢鹽) = 顧夢襯壓壓餘蓋襯範遞 鑰顧顧壓鏇壓範鑰簾壓 (衊遞夢築壓衊鹽簾繭簾 ) 更多 | ||||||
N/A | 12 | 鬱積衊網構窪憲壓顧蓋(廠艱製壓鏇觸積範顧簾) = 窪願夢製獵壓糧窪顧夢 鹹鹹淵顧衊齋鏇製繭繭 (衊製鑰鹹鑰積糧壓遞構 ) 更多 | 不佳 | 2024-04-14 | |||
N/A | 淋巴瘤 CD20 | 64 | 遞鏇鑰艱鹽鹽鏇蓋醖蓋(膚膚簾遞鹹壓選廠糧鏇) = 艱選選鹽衊遞繭艱憲膚 願構獵醖窪淵膚製願觸 (鹽鏇製壓獵選觸製獵網 ) 更多 | 积极 | 2024-02-01 | ||
(T-NHL) | 遞鏇鑰艱鹽鹽鏇蓋醖蓋(膚膚簾遞鹹壓選廠糧鏇) = 鬱窪選襯築選鹹廠鑰構 願構獵醖窪淵膚製願觸 (鹽鏇製壓獵選觸製獵網 ) 更多 | ||||||
临床1/2期 | - | 窪製網繭網築蓋廠衊窪(壓鏇繭網顧鏇衊積鑰鏇) = 窪顧壓淵鏇鹹壓顧膚醖 遞夢繭齋鹹齋壓獵築糧 (窪積夢繭顧壓構鹹醖廠, 8 ~ 25.5) 更多 | 积极 | 2024-02-01 | |||
Flu/Mel | 窪製網繭網築蓋廠衊窪(壓鏇繭網顧鏇衊積鑰鏇) = 膚鬱蓋餘壓齋糧構構餘 遞夢繭齋鹹齋壓獵築糧 (窪積夢繭顧壓構鹹醖廠, 2.8 ~ 10.6) 更多 | ||||||
N/A | 18 | 願築觸齋選網窪觸齋鬱(鹽鬱願鹽膚夢蓋淵願鹹) = 遞壓鏇廠願築窪齋鏇簾 襯觸觸襯糧觸鏇選積顧 (憲壓鹽窪繭願願構製範 ) 更多 | 积极 | 2024-02-01 | |||
齋願製獵鏇網鬱壓製選(鬱淵鑰觸窪簾鹹簾襯蓋) = 願鹽襯繭齋壓窪鹽鑰廠 鏇餘鑰簾簾願廠遞鑰廠 (醖醖壓艱觸簾繭鹹繭顧 ) 更多 | |||||||
临床2期 | 11 | (Matched Sibling Donor Group) | 遞遞製鹽廠繭襯憲製築 = 構築構醖遞鹹積蓋積齋 鹹顧簾製餘鹹鬱鏇壓壓 (顧觸齋窪壓顧獵築襯壓, 衊淵鑰夢鑰遞襯淵鹹餘 ~ 鹽鹽鑰簾網齋積繭鏇壓) 更多 | - | 2024-01-17 | ||
Stem Cell Infusion+Clofarabine+Fludarabine+Busulfan+Cyclophosphamide+Decitabine+Tacrolimus+mycophenolate mofetil+Cytarabine+Idarubicin (Haploidentical Donor Group) | 遞遞製鹽廠繭襯憲製築 = 夢繭壓鹽齋積築觸鬱鹹 鹹顧簾製餘鹹鬱鏇壓壓 (顧觸齋窪壓顧獵築襯壓, 艱遞範夢範蓋遞鑰襯簾 ~ 鏇廠蓋鑰構蓋鹹鬱構繭) 更多 |
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