此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

吡妥布替尼 (LOXO-305) 与苯达莫司汀联合利妥昔单抗 (BR) 在未经治疗的慢性淋巴细胞白血病 (CLL)/小淋巴细胞淋巴瘤 (SLL) 患者中的研究 (BRUIN-CLL-313)

2026年9月24日更新者：Loxo Oncology, Inc.

Pirtobrutinib (LOXO-305) 与苯达莫司汀加利妥昔单抗联合治疗未经治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者的 3 期开放标签随机研究

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

282

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- - Beijing、中国、100730
    - Beijing Hospital
  - Chongqing、中国、400030
    - Chongqing Cancer Hospital
  - Zhengzhou、中国、450008
    - Henan Cancer Hospital
- Anhui
  - Hefei、Anhui、中国、233004
    - Anhui Provincial Cancer Hospital
- Beijing Municipality
  - Beijing、Beijing Municipality、中国、100191
    - Peking University Third Hospital
  - Beijing、Beijing Municipality、中国、100034
    - Peking University First Hospital
- Guangdong
  - Guangzhou、Guangdong、中国、510120
    - The First Affiliated Hospital of Guangzhou Medical University
- Hubei
  - Wuhan、Hubei、中国、430022
    - Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Hunan
  - Changsha、Hunan、中国、410013
    - Hunan Cancer Hospital
  - Changsha、Hunan、中国、410008
    - Xiangya Hospital Central South University
- Inner Mongolia
  - Hohhot、Inner Mongolia、中国、010050
    - The Affiliated Hospital of Inner Mongolia Medical University
- Jiangxi
  - Nanchang、Jiangxi、中国、330006
    - The First Affiliated Hospital of Nanchang University
- Liaoning
  - Shenyany、Liaoning、中国、110022
    - Shengjing Hospital of China Medical University
- Nanjing
  - Nanjing、Nanjing、中国、210029
    - Jiangsu Province Hospital
- Shanghai Municipality
  - Changning District、Shanghai Municipality、中国、200050
    - Shanghai Tongren Hospital
- Sichuan
  - Chengdu、Sichuan、中国、610041
    - West China Hospital of Sichuan University
- Tianjin Municipality
  - Tianjin、Tianjin Municipality、中国、300060
    - Tianjin Medical University Cancer Institute and Hospital
  - Tianjin、Tianjin Municipality、中国、300020
    - Institute of hematology&blood disease hospital
- Zhejiang
  - Hangzhou、Zhejiang、中国、311100
    - The First People's Hospital of Hangzhou Linping District
俄罗斯
- - Saint Petersburg、俄罗斯、197022
    - Academician I.P. Pavlov First St-Petersburg State Medical University
保加利亚
- - Plovdiv、保加利亚、4000
    - UMHAT "Sveti Georgi" EAD
  - Sofia、保加利亚、1431
    - UMHAT 'Sv. Ivan Rilski', EAD
  - Sofia、保加利亚、1797
    - "SHATHD" EAD, Sofia
  - Stara Zagora、保加利亚、6003
    - UMHAT - Prof. Dr. Stoyan Kirkovich" AD
匈牙利
- - Debrecen、匈牙利、4032
    - Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
  - Nyíregyháza、匈牙利、4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Székesfehérvár、匈牙利、8000
    - Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
台湾
- - Changhua、台湾、50544
    - Chang Bing Show Chwan Memorial Hospital
  - Taichung、台湾、40447
    - China Medical University Hospital
  - Taipei、台湾、10002
    - National Taiwan University Hospital
  - Taoyuan City、台湾、333
    - Chang Gung Memorial Hospital - Linkou
奥地利
- - Salzburg、奥地利、5020
    - Uniklinikum Salzburg
  - Vienna、奥地利、1160
    - Klinik Ottakring
巴西
- Rio Grande do Sul
  - Porto Alegre、Rio Grande do Sul、巴西、90035-903
    - Hospital de Clinicas de Porto Alegre
  - Porto Alegre、Rio Grande do Sul、巴西、90050-170
    - Irmandade da Santa Casa de Misericórdia de Porto Alegre
  - Porto Alegre、Rio Grande do Sul、巴西、90110270
    - Centro Gaucho Integrado - Mae de Deus Center
- São Paulo
  - Campinas、São Paulo、巴西、13083-878
    - Hemocentro Unicamp
  - Jaú、São Paulo、巴西、17210120
    - Fundação Doutor Amaral Carvalho
意大利
- - Bergamo、意大利、24127
    - Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  - Brescia、意大利、25123
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  - Meldola、意大利、47014
    - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  - Milan、意大利、20122
    - Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  - Milan、意大利、20162
    - ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
  - Monza、意大利、20900
    - Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  - Novara、意大利、28100
    - Azienda Ospedale Maggiore Della Carita
  - Perugia、意大利、06132
    - Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
  - Ravenna、意大利、48020
    - Ospedale Santa Maria delle Croci
  - Terni、意大利、05100
    - Azienda Ospedaliera Santa Maria Terni
  - Trieste、意大利、34125
    - Azienda sanitaria integrata università di Trieste
- Potenza
  - Rionero in Vulture、Potenza、意大利、85028
    - Irccs Crob
捷克语
- - Brno、捷克语、62500
    - Fakultni nemocnice Brno
  - Hradec Králové、捷克语、500 05
    - Fakultni nemocnice Hradec Kralove
新西兰
- - Christchurch、新西兰、8011
    - Christchurch Hospital
  - Papatoetoe、新西兰、2025
    - Middlemore Clinical Trials
- Auckland
  - Takapuna、Auckland、新西兰、0622
    - North Shore Hospital, Haematology Research
- Bay of Plenty
  - Tauranga、Bay of Plenty、新西兰、3112
    - Tauranga Hospital
日本
- - Aomori、日本、030-8553
    - Aomori Prefectural Centeral Hospital
  - Fukoka-ken、日本、806 8501
    - JCHO Kyushu Hospital
- Aichi-ken
  - Nagoya、Aichi-ken、日本、467-8602
    - Nagoya City University Hospital
- Chiba
  - Chiba、Chiba、日本、260-8717
    - Chiba Cancer Center
- Fukui
  - Yoshida-Gun、Fukui、日本、910-1193
    - Fukui Medical University Hospital
- Hokkaido
  - Sapporo、Hokkaido、日本、0030006
    - Hokuyukai Sapporo Hokuyu Hospital
- Kochi
  - Nankoku、Kochi、日本、783-8505
    - Kochi Medical School Hospital
- Miyagi
  - Sendai、Miyagi、日本、980-8574
    - Tohoku University Hospital
  - Sendai、Miyagi、日本、9838520
    - NHO Sendai Medical Center
- Saitama
  - Koshigaya、Saitama、日本、343 8555
    - Dokkyo Medical University - Koshigaya Hospital
- Yamanshi
  - Chūō、Yamanshi、日本、409-3821
    - University of Yamanashi Hospital
法国
- - Le Mans、法国、72000
    - Hospitalier Le Mans
波兰
- - Biała Podlaska、波兰、21500
    - KO-MED Centra Kliniczne
  - Bydgoszcz、波兰、85-168
    - Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
  - Katowice、波兰、40519
    - Pratia Onkologia Katowice
  - Krakow、波兰、30727
    - Pratia MCM Krakow
  - Lublin、波兰、20-090
    - Centrum Onkologii Ziemi Lubelskiej
  - Torun、波兰、87-100
    - Nasz Lekarz Osrodek Badan Klinicznych
  - Warsaw、波兰、02781
    - Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
  - Wroclaw、波兰、50-367
    - Uniwersytecki Szpital Kliniczny Klinika
- Legnica
  - Iwaszkiewicza 5、Legnica、波兰、59-220
    - Wojewodzki Szpital Specjalistyczny
- Lubelskie V
  - Lublin、Lubelskie V、波兰、20081
    - Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
- Pomeranian Voivodeship
  - Gdansk、Pomeranian Voivodeship、波兰、80214
    - Uniwersyteckie Centrum Kliniczne
- Poznan
  - Skorzewo、Poznan、波兰、60 185
    - Centrum Medyczne Pratia Poznan
澳大利亚
- New South Wales
  - Liverpool、New South Wales、澳大利亚、2170
    - Liverpool Hospital
  - Wentworthville、New South Wales、澳大利亚、2145
    - Westmead Hospital
- Victoria
  - Frankston、Victoria、澳大利亚、3199
    - Peninsula Private Hospital
罗马尼亚
- - Bucharest、罗马尼亚、022328
    - Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
  - Cluj-Napoca、罗马尼亚、400015
    - Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
  - Iași、罗马尼亚、700483
    - Institutului Regional de Oncologie IASI
- Dolj
  - Craiova、Dolj、罗马尼亚、200143
    - Spitalul Clinic Municipal Filantropia Craiova
美国
- California
  - Los Angeles、California、美国、90027
    - California Research Institute
  - Whittier、California、美国、90603
    - Innovative Clinical Research Institute
- Florida
  - Coral Springs、Florida、美国、33065
    - Oncology-Hematology Associates of West Broward
- New Jersey
  - Brick、New Jersey、美国、08724
    - New Jersey Center for Cancer Research
- New York
  - Westbury、New York、美国、11590
    - Clinical Research Alliance, Inc.
英国
- England
  - Birmingham、England、英国、B9 5SS
    - Birmingham Heartlands Hospital
葡萄牙
- - Braga、葡萄牙、4710-243
    - Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
  - Lisbon、葡萄牙、1649035
    - Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  - Porto、葡萄牙、4200-072
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
西班牙
- - Barcelona、西班牙、08041
    - Hospital de la Santa Creu i Sant Pau
  - Madrid、西班牙、28040
    - Hospital Universitario Fundación Jiménez Díaz
  - Seville、西班牙、41013
    - Hospital Universitario Virgen del Rocío
  - Seville、西班牙、41014
    - Hospital Universitario Virgen de Valme
- Madrid, Comunidad de
  - Madrid、Madrid, Comunidad de、西班牙、28050
    - Hospital Universitario HM Sanchinarro
- Principality of Asturias
  - Oviedo、Principality of Asturias、西班牙、33011
    - Hospital Universitario Central de Asturias
韩国
- - Busan、韩国、47392
    - Inje Univ Busan Paik Hospital
- Incheon-gwangyeoksi [Incheon]
  - Namdong-gu、Incheon-gwangyeoksi [Incheon]、韩国、21565
    - Gachon University Gil Medical Center
- Seoul
  - Seocho-Gu、Seoul、韩国、06591
    - The Catholic University of Korea-Seoul St. Mary's Hospital
- Seoul, Korea
  - Seoul、Seoul, Korea、韩国、03080
    - Seoul National University Hospital
- Seoul-teukbyeolsi [Seoul]
  - Seoul、Seoul-teukbyeolsi [Seoul]、韩国、03722
    - Severance Hospital, Yonsei University Health System
  - Seoul、Seoul-teukbyeolsi [Seoul]、韩国、06351
    - Samsung Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate organ function
Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

Exclusion Criteria:

Known or suspected Richter's transformation at any time preceding enrollment
Prior systemic therapy for CLL/SLL
Presence of 17p deletion
Central nervous system (CNS) involvement
Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
Significant cardiovascular disease
Active hepatitis B or hepatitis C
Active cytomegalovirus (CMV) infection
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
Concurrent use of investigational agent or anticancer therapy except hormonal therapy
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Vaccination with a live vaccine within 28 days prior to randomization
Patients with the following hypersensitivity:
- Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
- Prior significant hypersensitivity to rituximab

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

武器和干预

参与者组/臂参与者组/臂根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。	干预/治疗干预/治疗作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：Arm A - Pirtobrutinib Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.	药品：Pirtobrutinib Oral 其他名称： LOXO-305 LY3527727
有源比较器：Arm B - Bendamustine Plus Rituximab Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).	药品：Bendamustine IV 其他名称：特兰达乐凡特核糖芥背叛者药品：Rituximab IV 其他名称：利妥昔单抗美罗华里亚布尼 Ruxience 特鲁希玛

参与者组/臂

干预/治疗

实验性的：Arm A - Pirtobrutinib

Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.

药品：Pirtobrutinib

Oral

其他名称：

LOXO-305
LY3527727

有源比较器：Arm B - Bendamustine Plus Rituximab

Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).

药品：Bendamustine

其他名称：

特兰达
乐凡特
核糖芥
背叛者

药品：Rituximab

其他名称：

利妥昔单抗
美罗华
里亚布尼
Ruxience
特鲁希玛

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC) 大体时间：From randomization until documented disease progression or death (up to 40 months)	PFS, as assessed by IRC, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.	From randomization until documented disease progression or death (up to 40 months)

次要结果测量

结果测量	措施说明	大体时间
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator 大体时间：From randomization until documented disease progression or death (up to 40 months)	PFS, as assessed by investigator, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.	From randomization until documented disease progression or death (up to 40 months)
To Evaluate the Effectiveness of Arm A Compared to Arm B: Overall Survival (OS) 大体时间：Up to approximately 5 years	Assessments of effectiveness include OS, assessed by investigator	Up to approximately 5 years
Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator 大体时间：From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)	TTNT is defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) including the first dose date of pirtobrutinib for Arm B participants who crossed over to receive pirtobrutinib if applicable or death due to any cause, whichever occurs first.	From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by IRC 大体时间：From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)	ORR, as assessed by IRC, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.	From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by Investigator 大体时间：From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)	ORR, as assessed by investigator, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.	From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC 大体时间：From first documented response until the first documented disease progression or death (up to 35 months)	DoR, as assessed by IRC, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.	From first documented response until the first documented disease progression or death (up to 35 months)
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by Investigator 大体时间：From first documented response until the first documented disease progression or death (up to 35 months)	DoR, as assessed by investigator, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.	From first documented response until the first documented disease progression or death (up to 35 months)
Arm A Compared to Arm B: Time to Worsening (TTW) of CLL/SLL-related Symptoms as Measured by the EORTC QLQ-C30 and IL-58 大体时间：From randomization up to 37 months	A measure of CLL/SLL-related symptoms (CLL/SLL-related Symptoms score) was derived from 13 items: appetite loss, fatigue (3 items), pain, nausea, dyspnea, and insomnia from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and night sweats, fever/chills, and fatigue (3 items) from selected items of the EORTC Item Library set 58 (IL-58). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing worse symptoms. TTW of CLL/SLL-related symptoms was defined as the time from randomization to the earliest date of the first sustained worsening in its score from baseline, meeting or exceeding the meaningful within-person change (MWPC) threshold of +5.12 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.	From randomization up to 37 months
Arm A Compared to Arm B: Time to Worsening (TTW) of Physical Functioning as Measured by the Physical Function Domain of the EORTC-QLQ-C30 大体时间：From randomization up to 37 months	Physical Functioning was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30) Physical Function (PF) scale consisting of 5 items to measure the impact of the disease and its treatment on a participant's ability to perform everyday physical activities, calculated from responses to the five items, each scored on a 4 point scale (1 = not at all to 4 = very much). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing better functioning. TTW of PF was defined as the time from randomization to the earliest date of the first sustained worsening from baseline, with a decline in the meaningful within-person change (MWPC) threshold of -13.33 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.	From randomization up to 37 months

其他结果措施

结果测量	措施说明	大体时间
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator 大体时间：From randomization until death from any cause (up to 41 months)	Overall survival (OS) is defined as the time from randomization until death from any cause. A descriptive analysis of OS was pre-specified based on the primary endpoint data cutoff.	From randomization until death from any cause (up to 41 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Loxo Oncology, Inc.

合作者

Eli Lilly and Company

调查人员

研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

<p>A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)</p>

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月23日

初级完成 (实际的)

2025年7月11日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2021年8月24日

首先提交符合 QC 标准的

2021年8月24日

首次发布 (实际的)

2021年8月27日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

吡妥布替尼 (LOXO-305) 与苯达莫司汀联合利妥昔单抗 (BR) 在未经治疗的慢性淋巴细胞白血病 (CLL)/小淋巴细胞淋巴瘤 (SLL) 患者中的研究 (BRUIN-CLL-313)

Pirtobrutinib (LOXO-305) 与苯达莫司汀加利妥昔单抗联合治疗未经治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者的 3 期开放标签随机研究

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

合作者

调查人员

出版物和有用的链接

一般刊物

有用的网址

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

药物和器械信息、研究文件

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