ChiCTR2500114564 版本V1.0 版本创建时间2025/12/15 11:07:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500114564 

最近更新日期：

Date of Last Refreshed on：

2025-12-15 11:07:29 

注册时间：

Date of Registration：

2025-12-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项在既往接受过BTK抑制剂治疗的复发/难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者中比较HBW-3220胶囊与研究者选择的治疗方案的III期、开放性、随机研究

Public title：

A Phase III, Open-Label, Randomized Study of HBW-3220 Capsules Compared to Investigator's Choice in Participants With Relapsed/?Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Bruton Tyrosine Kinase (BTK) Inhibitors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项在既往接受过BTK抑制剂治疗的复发/难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者中比较HBW-3220胶囊与研究者选择的治疗方案的III期、开放性、随机研究

Scientific title：

A Phase III, Open-Label, Randomized Study of HBW-3220 Capsules Compared to Investigator's Choice in Participants With Relapsed/?Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Bruton Tyrosine Kinase (BTK) Inhibitors

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

于迪 

研究负责人：

邱录贵; 周可树 

Applicant：

Di Yu 

Study leader：

Lugui Qiu; Keshu Zhou 

申请注册联系人电话：

Applicant telephone：

+86 28 8701 4968

研究负责人电话：

Study leader's telephone：

+86 138 2126 6636

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

diyu@hyperwaypharma.com

研究负责人电子邮件：

Study leader's E-mail：

qiulg@ihcams.ac.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国四川省成都市武侯区科园南路88号天府生命科技园B4栋8楼

研究负责人通讯地址：

中国天津市静海区团泊大道28号

Applicant address：

8th Floor, Building B4, Tianfu Life Science Park, 88 Keyuan South Road, Wuhou District, Chengdu City, Sichuan Province, China

Study leader's address：

No. 28, Tongbo Avenue, Jinghai District, Tianjin, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

成都海博为药业有限公司

Applicant's institution：

Hyperway Pharmaceutical Co.,Ltd.

研究负责人所在单位：

中国医学科学院血液病医院

Affiliation of the Leader：

Chinese Academy of Medical Sciences Hospital of Hematology

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

XY2025072-EC-1

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中国医学科学院血液病医院（中国医学科学院血液学研究所）伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of the Institute of Hematology, Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-03 00:00:00

伦理委员会联系人：

王启柔

Contact Name of the ethic committee：

Qirou Wang

伦理委员会联系地址：

中国天津市静海区团泊大道28号

Contact Address of the ethic committee：

No. 28, Tongbo Avenue, Jinghai District, Tianjin, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 22 2360 8025

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ec@ihcams.ac.cn

研究实施负责（组长）单位：

中国医学科学院血液病医院

Primary sponsor：

Chinese Academy of Medical Sciences Hospital of Hematology

研究实施负责（组长）单位地址：

中国天津市静海区团泊大道28号

Primary sponsor's address：

No. 28, Tongbo Avenue, Jinghai District, Tianjin, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都海博为药业有限公司

具体地址：

中国四川省成都市武侯区科园南路88号天府生命科技园B4栋8楼

Institution
hospital：

Hyperway Pharmaceutical Co.,Ltd.

Address：

8th Floor, Building B4, Tianfu Life Science Park, 88 Keyuan South Road, Wuhou District, Chengdu City, Sichuan Province, China

经费或物资来源：

成都海博为药业有限公司

Source(s) of funding：

Hyperway Pharmaceutical Co.,Ltd

Target disease：

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 III期临床试验 

Study phase：

3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1） 主要目的： 通过评估无进展生存期（PFS），比较 HBW-3220 单药治疗与研究者选择的治疗方案【苯达莫司汀联合利妥昔单抗（BR）或大剂量甲泼尼龙联合利妥昔单抗（HDMP+R）】的有效性。 2）次要目的： 基于总缓解率（ORR）及事件发生时间，评价 HBW-3220 单药治疗相较于研究者选择的治疗方案（BR 或 HDMP+R）的有效性； 评估各治疗组的安全性； 通过 EORTC QLQ-C30 问卷评估受试者报告的生活质量变化； 评估HBW-3220的药代动力学（PK）特征。  

Objectives of Study：

1.Primary Objective: To compare the efficacy of HBW-3220 monotherapy versus the investigator's choice of treatment regimen [Bendamustine combined with Rituximab (BR) or High-Dose Methylprednisolone combined with Rituximab (HDMP+R)] by assessing Progression-Free Survival (PFS). 2. Secondary Objectives: To evaluate the efficacy of HBW-3220 monotherapy compared to the investigator's choice of treatment regimen (BR or HDMP+R) based on Overall Response Rate (ORR) and time-to-event endpoints; To assess the safety profile of each treatment group; To evaluate patient-reported changes in quality of life using the EORTC QLQ-C30 questionnaire; To characterize the pharmacokinetic (PK) profile of HBW-3220.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄≥18周岁。 2.东部肿瘤协作组（ECOG）体能状态评分为0~2分。 3.经研究者判断，预计生存期≥3个月。 4.根据病理确诊的CLL/SLL患者需同时满足以下条件：存在治疗指征（详见附件二），且具备至少一项可测量病灶，包括外周血B淋巴细胞计数≥5×10^9/L、影像学确认的淋巴结肿大（基线LDi＞1.5cm）或由CLL直接导致的肝肿大/脾大。 5.既往接受过共价BTK抑制剂治疗后出现治疗失败、缓解后复发或不耐受。 6.在开始HBW-3220给药前7天内血液学状态满足以下要求： （1）中性粒细胞绝对计数（ANC）≥0.75×10^9/L且不需要生长因子。如果有骨髓受累，可以在给药之前的任何时间使用生长因子来达到0.75×10^9/L阈值； （2）血小板计数≥50×10^9/L，若有骨髓受累则需≥30×10^9/L【给药前7天内未输注血小板或应用生长因子】； （3）血红蛋白≥80g/L，若有骨髓受累则需≥60g/L【给药前7天内允许输血或应用生长因子】。 7.凝血功能：活化部分凝血活酶时间（aPTT）、凝血酶原时间（PT）和国际标准化比值（INR）≤1.5×ULN。 8.肝功能：a.丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）≤2.5×ULN，或存在肝脏累及的患者≤5×ULN；b.总胆红素≤1.5×ULN，或存在肝脏累及和/或Gilbert综合征的患者≤3×ULN。 9.肾功能：血清肌酐（Scr）≤1.5×ULN，或使用Cockcroft-Gault公式计算的血清肌酐清除率（Ccr）≥40mL/min。 10.任何与既往治疗相关的非血液学毒性应恢复至1级或正常（根据NCI CTCAE版本5.0，脱发除外）。 11.自愿签署知情同意书，并理解且同意遵循试验治疗方案和访视计划。

Inclusion criteria

1. Age >=18 years old. 2. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2. 3. Predicted survival of >=3 months, as judged by the investigator. 4. Patients with pathology-confirmed CLL/SLL were required to have both the presence of treatment indications (see Appendix II) and at least one measurable lesion, including peripheral B lymphocyte count >=5×10^9/L, radiologically confirmed lymphadenopathy (baseline LDi > 1.5cm), or hepatomegaly/splenomegaly directly due to CLL. 5. Treatment failure, relapse after remission, or intolerance after previous treatment with a covalent BTK inhibitor. 6. Hematologic status within 7 days before starting HBW-3220: (1) Absolute neutrophil count (ANC) >=0.75×10^9/L and no growth factors were required. Growth factors could be administered at any time before administration to reach the 0.75×10^9/L threshold if bone marrow involvement was present. (2) Platelet count >=50×10^9/L or >=30×10^9/L if bone marrow involvement occurs (platelet transfusion or growth factors not used within 7 days before administration); (3) hemoglobin >=80g/L, or >=60g/L if bone marrow involvement was present (blood transfusion or growth factors were allowed within 7 days before administration). 7. Coagulation function: activated partial thromboplastin time (aPTT), prothrombin time (PT) and international normalized ratio (INR) <=1.5×ULN. 8. Liver function: a. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×ULN, or patients with liver involvement <=5×ULN; b. Total bilirubin <=1.5×ULN, or <=3×ULN in patients with liver involvement and/or Gilbert's syndrome. 9. Renal function: serum creatinine (Scr) <=1.5×ULN, or serum creatinine clearance (Ccr) calculated by Cockcroft-Gault formula >=40mL/min. 10. Any nonhematologic toxicity related to previous therapy should revert to grade 1 or normal (except alopecia according to NCI CTCAE version 5.0). 11. Voluntarily provide written informed consent and understand and agree to follow the trial regimen and visit plan.

排除标准：

1）既往接受过下列任何一项治疗： a.首次研究给药前4周内或5个半衰期内（以时间较短者为准）接受过非靶向小分子化疗药物、靶向治疗、抗肿瘤免疫治疗或试验性药物； b.首次研究给药前4周内接受过骨盆、颅骨、胸骨等含骨髓区域的放疗或全脑放疗；1周内接受过其他姑息性局部放疗； c.首次研究给药前1周内使用过具有抗肿瘤作用的中药或中成药； d.首次研究给药前2周内接受类固醇激素治疗，且剂量超过以下标准：用于非肿瘤疾病时＞2.25 mg/天地塞米松或等效剂量，用于肿瘤疾病时＞5 mg/天地塞米松或等效剂量；允许局部外用、吸入或临时使用糖皮质激素； e.首次研究给药前4周内使用过半衰期未知的试验性药物。 2）首次研究给药前4周内接种过活疫苗。 3）研究期间计划同时使用其他全身性抗肿瘤治疗。 4）首次研究给药前4周内或研究期间需持续使用华法林、维生素K拮抗剂等抗凝药物，或存在出血倾向、凝血功能障碍。 5）开始HBW-3220治疗前7天或5个半衰期内（以时间较长者为准）使用过强效CYP3A4抑制剂或诱导剂、或强效P-糖蛋白（P-gp）抑制剂，包括但不限于：伊曲康唑、酮康唑、克拉霉素、利福平、卡马西平、苯妥英、圣约翰草等。 6）首次研究给药前28天内接受重大手术（不包括血管通路置入、活检或激光眼科手术）。 7）开始HBW-3220治疗前6个月内接受过异基因或自体干细胞移植（SCT）或嵌合抗原受体T细胞（CAR-T）治疗。 8）患有控制不佳的活动性自身免疫性血细胞减少症（如特发性血小板减少性紫癜[ITP]），且在入组前28天内需新开始治疗或增加剂量以维持血细胞计数。 9）已知或高度怀疑存在Richter转化、幼淋巴细胞白血病，或淋巴瘤累及中枢神经系统（包括既往原发性CNS淋巴瘤已达完全缓解者）。 10）患有具有临床意义的控制不佳的心血管疾病，定义为：a. 开始HBW-3220治疗前2个月内存在不稳定性心绞痛；b.开始HBW-3220治疗前6个月内发生心肌梗死；c.开始HBW-3220治疗前12个月内通过任何方法测得的左心室射血分数（LVEF）≤45%；d.根据纽约心脏协会功能分级定义，患有任何3级或4级心脏疾病；e.控制不佳的或有症状的心律失常，f.控制不佳的高血压（收缩压＞159mmHg或舒张压＞99mmHg）。 11）筛选期3次心电图（ECG）中至少2次显示，按Fridericia公式校正的QT间期（QTcF）：男性≥450 msec，女性≥470 msec。QTcF使用Fridericia公式（QTcF）计算：QTcF=QT/（RR^0.33）。 12）首次给药前6个月内发生脑卒中、颅内出血病史。 13）首次给药前3年内除CLL/SLL外曾罹患其他恶性肿瘤（已明显治愈或近3年未复发的局部肿瘤除外，如基底/鳞状细胞皮肤癌、浅表膀胱癌、原位前列腺癌、宫颈原位癌或乳腺原位癌等）。 14）既往或目前有严重的肺纤维化、肺栓塞、间质性肺炎、尘肺、放射性肺炎、药物相关肺炎、肺功能严重受损等。 15）既往BTK抑制剂治疗期间发生大出血事件（大出血定义：伴有血流动力学不稳定的危及生命的出血；血红蛋白下降≥2 g/dL的出血；关键部位/器官出血，如腹膜后、关节、心包、硬膜外、颅内出血，或伴腔室综合征的肌肉出血等）。 16）存在需要药物治疗的活动性的全身性的细菌、病毒、真菌或寄生虫感染（真菌指甲感染除外），且经研究者判断不适合参加临床试验者。 17）人类免疫缺陷病毒（HIV）检测阳性，或存在活动性乙型肝炎感染（HBsAg 或 HBcAb 阳性且 HBV-DNA 检测结果高于正常值上限），或丙型肝炎（HCV抗体阳性且HCV-RNA阳性或高于正常值上限），活动性梅毒感染（既往感染经专科判断已治愈者可入选）。 18）存在难治性恶心呕吐、吞咽困难、吸收不良综合征、慢性胃肠道疾病、胃间隔术或减肥手术（如胃旁路术）、部分/完全肠梗阻、既往重大肠切除等，经判断可能严重影响药物吸收、分布、代谢或排泄。 19）妊娠或哺乳期女性；育龄期受试者不愿在研究治疗期间及末次给药后6个月内采用高效避孕措施（失败率＜1%）；禁止在研究期间及末次给药后6个月内捐献精子或卵子、哺乳。 20）已知对HBW-3220、苯达莫司汀、利妥昔单抗、甲泼尼龙琥珀酸钠的活性成分或辅料存在严重过敏或超敏反应史。 21）当前或近6个月内存在酒精滥用（男性＞40 g/日，女性＞20 g/日（1标准杯≈14g酒精））或药物滥用史。 22）其他严重急性/慢性躯体疾病或精神疾病，包括近1年内或当前存在自杀意念/行为；存在可能增加参与研究风险、干扰结果判读的实验室异常或其他风险因素。 23）经研究者判断，存在任何其他可能影响受试者安全或研究执行、结果解释的临床状况或社会家庭因素

Exclusion criteria：

1) Prior treatment with any of the following: A. receipt of a nontargeted small-molecule chemotherapeutic agent, targeted therapy, antitumor immunotherapy, or investigational agent within 4 weeks or five half-lives, whichever was shorter, before the first study dose; b. Radiotherapy to bone marrow-containing regions of the pelvis, skull, sternum, or whole brain within 4 weeks before the first study dose; Other palliative local radiotherapy within 1 week; c. Use of Chinese medicine or Chinese patent medicine with anti-tumor effect within 1 week before the first study drug administration; d. receive steroid therapy within 2 weeks before the first study dose in excess of the following criteria: > 2.25 mg/ day or equivalent dexamethasone for nonneoplastic disease and > 5 mg/ day or equivalent dexamethasone for neoplastic disease; Topical, inhaled, or temporary use of glucocorticoids was allowed. e. An investigational drug with an unknown half-life was administered within 4 weeks before the first study dose. 2) received live vaccine within 4 weeks before the first study dose. 3) Planned concomitant use of other systemic antitumor therapies during the study. 4) patients required continuous use of anticoagulants such as warfarin or vitamin K antagonists within 4 weeks before or during the study, or had bleeding tendency or coagulopathy. 5) use of potent CYP3A4 inhibitors or inducers, or potent P-glycoprotein (P-gp) inhibitors within 7 days or 5 half life (the longer) prior to initiation of HBW-3220 treatment, including but not limited to: itraconazole, ketoconazole, clarithromycin, rifampicin, carbazepine, phenytoin, St. 6) major surgery (excluding vascular access placement, biopsy, or laser eye surgery) within 28 days before the first study dose. 7) allogeneic or autologous stem cell transplantation (SCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 6 months before starting HBW-3220 therapy. 8) have active, poorly controlled autoimmune cytopenias (e.g., idiopathic thrombocytopenic purpura [ITP]) requiring new treatment or a dose increase to maintain blood counts within 28 days before enrollment. 9) known or highly suspected Richter's transformation, prolymphocytic leukemia, or central nervous system involvement (including in patients with prior primary CNS lymphoma in complete remission). 10) clinically significant uncontrolled cardiovascular disease, defined as: a. unstable angina within 2 months before HBW-3220 initiation; b. myocardial infarction within 6 months before starting HBW-3220; c. Left ventricular ejection fraction (LVEF) <=45%, as measured by any method, within 12 months before starting HBW-3220 therapy; d. any cardiac disease of class 3 or 4, as defined by the New York Heart Association functional class; " e. poorly controlled or symptomatic arrhythmias, and f. poorly controlled hypertension (systolic blood pressure > 159mmHg or diastolic blood pressure > 99mmHg)." 11)QT intervals corrected according to Fridericia's formula (QTcF) were >=450 msec in men and ≥470 msec in women on at least two of three electrocardiograms (ECG) obtained during screening. QTcF was calculated using Fridericia's formula (QTcF) : QTcF=QT/ (RR^0.33). 12) a history of stroke or intracranial hemorrhage within 6 months before the first dose. 13) patients with malignant tumors other than CLL/SLL within 3 years before the first dose (except for local tumors that have been obviously cured or have not recurs in the past 3 years, such as basal/squamous cell skin cancer, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, or breast cancer in situ, etc.). 14) had a history or current history of severe pulmonary fibrosis, pulmonary embolism, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc. 15) major bleeding event (major bleeding was defined as life-threatening bleeding with hemodynamic instability; bleeding with hemoglobin decrease >=2 g/dL; bleeding in critical sites/organs, such as retroperitoneal, joint, pericardial, epidural, intracranial, or muscle bleeding with compartment syndrome, etc.) during previous BTK inhibitor treatment. 16) had an active systemic bacterial, viral, fungal, or parasitic infection requiring medical treatment (other than fungal nail infection) that was judged by the investigator to be ineligible for clinical trial enrollment. 17) test positive for human immunodeficiency virus (HIV) or have active hepatitis B infection (positive for HBsAg or HBcAb and HBV-DNA test result above the upper limit of normal) or hepatitis C (positive for HCV antibody and HCV-RNA positive or above the upper limit of normal); Active syphilis infection (eligible if previous infection had been cured by specialist judgment). 18) have refractory nausea and vomiting, dysphagia, malabsorption syndrome, chronic gastrointestinal diseases, gastric septum or bariatric surgery (such as gastric bypass), partial/complete intestinal obstruction, and previous major bowel resection, which may seriously affect drug absorption, distribution, metabolism, or excretion. 19) pregnant or lactating women; Participants of childbearing age were unwilling to use highly effective contraceptives (failure rate < 1%) during study treatment and within 6 months after the last dose. Sperm or egg donation and breast-feeding during the study and for 6 months after the last dose were prohibited. 20) known history of severe allergic or hypersensitive reactions to HBW-3220, bendamustine, rituximab, methylprednisolone sodium succinate, active ingredients or excipients. 21) have current or recent history of alcohol abuse (> 40 g/ day for men and > 20 g/ day for women (1 standard drink ≈14g of alcohol)) or substance abuse. 22) other severe acute/chronic physical or mental diseases, including suicidal ideation/behavior in the past year or current; There are laboratory abnormalities or other risk factors that may increase the risk of participating in the study or interfere with the interpretation of the results. 23) the presence of any other clinical condition or social-family factor that may, in the judgment of the investigator, affect the safety of the subjects or the conduct of the study or the interpretation of the results

研究实施时间：

Study execute time：

从 From 2025-12-15 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-15 00:00:00 至 To 2027-01-31 00:00:00  

干预措施：

Interventions：

组别：

治疗组

样本量：

108

Group：

Treatment group

Sample size：

干预措施：

HBW-3220胶囊

干预措施代码：

Intervention：

HBW-3220capule

Intervention code：

组别：

对照组

样本量：

108

Group：

Control group

Sample size：

干预措施：

苯达莫司汀+利妥昔单抗/甲泼尼龙琥珀酸钠 + 利妥昔单抗

干预措施代码：

Intervention：

Bendamustine + rituximab/methylprednisolone sodium succinate + rituximab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津 

市(区县)：

  

Country：

China 

Province：

Tianjin  

City：

 

单位(医院)：

中国医学科学院血液病医院 

单位级别：

三级甲等 

Institution
hospital：

Chinese Academy of Medical Sciences Hospital of Hematology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-Free Survival (PFS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总体缓解率

指标类型：

次要指标

Outcome：

Overall Response Rate,ORR

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PK特征

指标类型：

次要指标

Outcome：

PK characteristics

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性

指标类型：

次要指标

Outcome：

Safety

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

EORTC QLQ-C30 问卷评估

指标类型：

次要指标

Outcome：

EORTC QLQ-C30 assessment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究由随机化统计师应用SAS软件生成受试者随机分配表，采用分层区组随机方法（分层因素为是否存在 del（17p）和/或 TP53 突变（是/否），以及既往是否接受过BCL2抑制剂治疗（是/否）），按1:1的比例随机分配至试验组（A组）或对照组（B组）。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study utilized SAS software by a randomization statistician to generate a subject randomization schedule. A stratified block randomization method was employed, with stratification factors including the presence or absence of del(17p) and/or TP53 mutation (yes/no) and prior treatment with a BCL2 inhibitor (yes/no). Participants were randomly assigned in a 1:1 ratio to either the experimental group (Arm A) or the control group (Arm B).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Electronic Data Capture, EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-12-15 11:07:29