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Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

2026年8月26日 更新者：BeOne Medicines

再発または難治性マントル細胞リンパ腫患者における Bcl-2 阻害剤 BGB-11417 の有効性、安全性、および薬物動態を評価するための単群非盲検多施設第 2 相試験

The study consists of two parts. Part 1 determines the safety and tolerability of sonrotoclax monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of sonrotoclax monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of sonrotoclax monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

125

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35294-0004
        • University of Alabama At Birmingham Hospital
    • Indiana
      • Fort Wayne、Indiana、アメリカ、46804
        • Fort Wayne Medical Oncology and Hematology
    • Louisiana
      • New Orleans、Louisiana、アメリカ、70112-2618
        • Tulane Cancer Center
    • Maryland
      • Columbia、Maryland、アメリカ、21044-3257
        • Maryland Oncology Hematology, Pa
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601-1915
        • Hackensack University Medical Center
    • Texas
      • Houston、Texas、アメリカ、77030-4009
        • The University of Texas Md Anderson Cancer Center
  • アルゼンチン
      • Ciudad Autonoma Buenos Aires、アルゼンチン、C1118AAT
        • Hospital Aleman
  • イギリス
      • Headington、イギリス、OX3 7LE
        • Oxford University Hospitals Nhs Trust Churchill Hospital
      • London、イギリス、NW1 2PG
        • University College Hospital
      • Metropolitan Borough of Wirral、イギリス、CH63 4JY
        • Clatterbridge Cancer Centre
  • イスラエル
      • Ashdod、イスラエル、7747629
        • Assuta Ashdod Medical Center
      • Jerusalem、イスラエル、9103102
        • Shaare Zedek Medical Center
  • イタリア
      • Meldola、イタリア、47014
        • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
  • スペイン
      • Barcelona、スペイン、08035
        • Hospital Universitario Vall Dhebron
      • Seville、スペイン、41013
        • Hospital Universitario Virgen Del Rocio
  • トルコ（Türkiye）
      • Ankara、トルコ（Türkiye）、06620
        • Ankara University Medical Faculty
      • Ankara、トルコ（Türkiye）、06620
        • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
      • Tevikiye、トルコ（Türkiye）、34365
        • Vkv American Hospital
  • ドイツ
      • Cologne、ドイツ、50937
        • Universitatsklinikum Koln, Innere Medizin I
      • Düsseldorf、ドイツ、40225
        • Universitatsklinikum Dusseldorf
  • フランス
      • Le Mans、フランス、72037
        • Centre Hospitalier Le Mans
      • Nantes、フランス、44000
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Paris、フランス、75015
        • Necker University Hospital
      • Paris、フランス、75013
        • Hopital Pitie Salpetriere Service Hematologie
      • PierreBenite、フランス、69495
        • Chu Hopital Lyon Sud
      • Tours、フランス、37000
        • Chu Tours Hopital Bretonneau Service Pneumologie 2
  • ブラジル
      • Curitiba、ブラジル、81520-060
        • Hospital Erasto Gaertner
      • Porto Alegre、ブラジル、90110-270
        • Hospital Mae de Deus
      • Ribeirão Preto、ブラジル、14051-140
        • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
      • Rio de Janeiro、ブラジル、22775-001
        • Instituto Americas Ensino, Pesquisa E Inovacao
      • Rio de Janeiro、ブラジル、22250-040
        • Oncoclinicas Rio de Janeiro Sa
      • Salvador、ブラジル、41253-190
        • Hospital Sao Rafael (Rede Dor)
      • São Paulo、ブラジル、05652-900
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • São Paulo、ブラジル、01508-010
        • Accamargo Cancer Center
      • São Paulo、ブラジル、05402-000
        • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
      • São Paulo、ブラジル、01401-004
        • Instituto Dor de Pesquisa E Ensino Sao Paulo
      • São Paulo、ブラジル、01323-001
        • Hospital Beneficencia Portuguesa de Sao Paulo
  • プエルトリコ
      • San Juan、プエルトリコ、00917
        • Auxilio Mutuo Cancer Center
  • ベルギー
      • Leuven、ベルギー、3000
        • University Hospitals Leuven
  • ポーランド
      • Gdansk、ポーランド、80-214
        • Uniwersyteckie Centrum Kliniczne
      • Krakow、ポーランド、30-727
        • Pratia McM Krakow
      • Lublin、ポーランド、20-090
        • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
  • 中国
    • Anhui
      • Hefei、Anhui、中国、230088
        • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • Beijing Cancer Hospital
      • Beijing、Beijing Municipality、中国、101100
        • Beijing Friendship Hospital, Capital Medical University(Tongzhou)
    • Fujian
      • Fuzhou、Fujian、中国、350014
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou、Guangdong、中国、510060
        • Sun Yat Sen University Cancer Center
      • Guangzhou、Guangdong、中国、510120
        • Guangdong Provincial Peoples Hospital Huifu Branch
    • Guangxi
      • Nanning、Guangxi、中国、530021
        • The Tumor Hospital Affiliated to Guangxi Medical University
    • Hainan
      • Haikou、Hainan、中国、570206
        • Hainan General Hospital
    • Henan
      • Zhengzhou、Henan、中国、450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou、Henan、中国、450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan、Hubei、中国、430030
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Jiangsu
      • Nantong、Jiangsu、中国、201203
        • Affiliated Hospital of Nantong University
      • Xuzhou、Jiangsu、中国、221000
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang、Jiangxi、中国、330029
        • Jiangxi Cancer Hospital
    • Liaoning
      • Shenyang、Liaoning、中国、110042
        • Liaoning Cancer Hospital and Institute
    • Ningxia
      • Yinchuan、Ningxia、中国、750004
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan、Shandong、中国、250117
        • Shandong Cancer Hospital
      • Qingdao、Shandong、中国、266555
        • The Affiliated Hospital of Qingdao University Branch West Coast
    • Shanxi
      • Taiyuan、Shanxi、中国、030013
        • Shanxi Provincial Cancer Hospital
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital, Sichuan University
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Xinjiang
      • Ürümqi、Xinjiang、中国、830000
        • Affiliated Cancer Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of MCL
  2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).
  3. Relapsed/refractory disease
  4. Presence of measurable disease
  5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
  7. Adequate organ function

Key Exclusion Criteria:

  1. Known central nervous system involvement by lymphoma
  2. Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
  3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
  4. Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
  5. Clinically significant cardiovascular disease.
  6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  7. Active fungal, bacterial or viral infection requiring systemic treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Part 1: Sonrotoclax 160 mg (Daily Ramp-up)

Participants received sonrotoclax at the target dose of 160 mg orally once a day (QD) after an approximately 4-week ramp-up schedule starting at 1 mg with daily dose increases until the target dose was reached. Participants received sonrotoclax until disease progression, unacceptable toxicity, or consent withdrawal.
薬：Sonrotoclax

Administered orally

他の名前：
  • BGB-11417
実験的：Part 1: Sonrotoclax 320 mg (Daily Ramp-up)

Participants received sonrotoclax at the target dose of 320 mg orally once a day after an approximately 4-week ramp-up schedule starting at 1 mg with daily dose increases until the target dose was reached. Participants received sonrotoclax until disease progression, unacceptable toxicity, or consent withdrawal.
薬：Sonrotoclax

Administered orally

他の名前：
  • BGB-11417
実験的：Part 2: Sonrotoclax 320 mg (Daily Ramp-up)

Participants received sonrotoclax at the target dose of 320 mg orally once a day after an approximately 4-week ramp-up schedule starting at 1 mg with daily dose increases until the target dose was reached. Participants received sonrotoclax until disease progression, unacceptable toxicity, or consent withdrawal.
薬：Sonrotoclax

Administered orally

他の名前：
  • BGB-11417
実験的：Part 2: Sonrotoclax 320 mg (Twice-weekly Ramp-up)

Participants received sonrotoclax at the target dose of 320 mg orally once a day after an approximately 4-week ramp-up schedule starting at 1 mg with twice-weekly dose increases until the target dose was reached. Participants received sonrotoclax until disease progression, unacceptable toxicity, or consent withdrawal.
薬：Sonrotoclax

Administered orally

他の名前：
  • BGB-11417

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
時間枠：From first dose in the ramp-up period through the first 3 weeks of treatment at the target dose (approximately 7 weeks)

DLTs included the following events without a clear alternative cause other than study drug:

Hematologic Toxicity:

  • Grade ≥ 3 febrile neutropenia;
  • Grade ≥ 3 thrombocytopenia lasting > 7 days or resulting in clinically significant bleeding;
  • Any Grade ≥ 4 hematological toxicities, except for Grade 4 neutropenia lasting ≤ 7 days with or without treatment, Grade 4 lymphopenia, or Grade 4 leukopenia.

Nonhematologic Toxicity:

• Any Grade ≥ 3 nonhematologic toxicity with the following exceptions:

  • Laboratory tumor lysis syndrome (TLS) defined by the Howard criteria that resolves (≤ Grade 1 or baseline) in ≤ 3 days;
  • Individual TLS-related laboratory adverse events that resolve (≤ Grade 1or baseline) in ≤ 3 days with or without treatment;
  • Grade 3 gastrointestinal toxicity that resolves to ≤ Grade 2 following therapeutic intervention in ≤ 7 days;
  • Asymptomatic biochemical laboratory abnormalities that resolve (≤ Grade 1 or baseline) in ≤ 7 days with or without supportive care.
From first dose in the ramp-up period through the first 3 weeks of treatment at the target dose (approximately 7 weeks)
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Treatment Discontinuation
時間枠：From first dose of study drug up to 30 days after last dose or the primary analysis data cut-off date, whichever occurred earlier; maximum duration of treatment was 31 months.

An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not.

A serious adverse event is any untoward medical occurrence that, at any dose:

  • Resulted in death
  • Was life-threatening
  • Required hospitalization or prolongation of existing hospitalization.
  • Resulted in disability/incapacity.
  • Was a congenital anomaly/birth defect.
  • Was considered a significant medical adverse event by the investigator or sponsor based on medical judgment.
From first dose of study drug up to 30 days after last dose or the primary analysis data cut-off date, whichever occurred earlier; maximum duration of treatment was 31 months.
Part 1: Number of Participants Experiencing Tumor Lysis Syndrome (TLS) Adverse Events
時間枠：From first dose of study drug up to 30 days after last dose or the primary analysis data cut-off date, whichever occurred earlier; maximum duration of treatment was 31 months.

Tumor lysis syndrome (TLS) occurs when large numbers of cancer cells die rapidly, releasing their contents (such as potassium, phosphorus, and nucleic acids) into the bloodstream faster than the kidneys can filter them out. This rapid breakdown causes a dangerous chain reaction of metabolic and electrolyte imbalances.
From first dose of study drug up to 30 days after last dose or the primary analysis data cut-off date, whichever occurred earlier; maximum duration of treatment was 31 months.
Part 2: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)
時間枠：Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

ORR is defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Lugano Classification for non-Hodgin lymphoma.
Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

二次結果の測定

結果測定
メジャーの説明
時間枠
Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Sonrotoclax After a Single Dose
時間枠：Ramp-up Week 1 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Ramp-up Week 1 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Sonrotoclax at Steady-State
時間枠：Target Dose Week 4 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Target Dose Week 4 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Part 1: Time to Maximum Observed Concentration of Sonrotoclax (Tmax) After a Single Dose
時間枠：Ramp-up Week 1 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Ramp-up Week 1 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Part 1: Time to Maximum Observed Concentration of Sonrotoclax (Tmax) at Steady State
時間枠：Target Dose Week 4 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Target Dose Week 4 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Part 1: Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax After a Single Dose
時間枠：Ramp-up Week 1 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Ramp-up Week 1 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State
時間枠：Target Dose Week 4 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Target Dose Week 4 Day 1 at predose, 2, 4, 6, and 8 hours post-dose
Part 1: Trough Plasma Concentration (Ctrough) at Steady State
時間枠：Target Dose Week 4 Day 1 at predose
Target Dose Week 4 Day 1 at predose
Part 1: Overall Response Rate Assessed by the Independent Review Committee (IRC)
時間枠：Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

ORR is defined as the percentage of participants who achieved a complete response (CR), or partial response (PR) per the Lugano classification for non-Hodgkin lymphoma.

IRC review for response assessments was only performed for Part 1 participants assigned to the 320 mg dose level.
Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 1: Overall Response Rate Assessed by the Investigator
時間枠：Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

ORR is defined as the percentage of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification for non-Hodgkin lymphoma.
Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 1: Duration of Response (DOR) Assessed by the IRC
時間枠：Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause; whichever occurred first, per the Lugano classification for non-Hodgkin lymphoma.

IRC review for response assessments was only performed for Part 1 participants assigned to the 320 mg dose level.

DOR was estimated using the Kaplan-Meier method.
Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 1: Duration of Response Assessed by the Investigator
時間枠：Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause, whichever occurred first. DOR was estimated using the Kaplan-Meier method.
Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 1: Progression Free Survival (PFS) Assessed by the IRC
時間枠：From first dose until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurred first.

IRC review for response assessments was only performed for Part 1 participants assigned to the 320 mg dose level.

PFS was estimated using the Kaplan-Meier method.
From first dose until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 1: Progression-free Survival Assessed by the Investigator
時間枠：From first dose until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method.
From first dose until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 1: Time to Response (TTR) as Assessed by the IRC
時間枠：Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in part 1 was 10.7 (0.1-31.6) months.

Time to response is defined as the time from start of treatment to first documentation of response (PR or better). IRC review for response assessments was only performed for Part 1 participants assigned to the 320 mg dose level.
Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in part 1 was 10.7 (0.1-31.6) months.
Part 1: Time to Response Assessed by the Investigator
時間枠：Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

TTR is defined as the time from start of treatment to first documentation of response (PR or better).
Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to one year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 1: Overall Survival (OS)
時間枠：From first dose until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.

Overall survival is defined as the time from the start of treatment to the date of death due to any cause. OS was estimated using the Kaplan-Meier method.
From first dose until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 1 was 10.7 (0.1-31.6) months.
Part 2: Overall Response Rate (ORR) Assessed by the Investigator
時間枠：Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

ORR is defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Lugano Classification for non-Hodgin lymphoma.
Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Duration of Response Assessed by the IRC
時間枠：Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

Duration of response is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause, whichever occurred first. DOR was estimated using the Kaplan-Meier method.
Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Duration of Response Assessed by the Investigator
時間枠：Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

Duration of response is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause, whichever occurred first. DOR was estimated using the Kaplan-Meier method.
Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Progression-free Survival Assessed by the IRC
時間枠：From first dose of study drug until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method.
From first dose of study drug until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Progression-free Survival Assessed by the Investigator
時間枠：From first dose of study drug until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method.
From first dose of study drug until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Time to Response Assessed by the IRC
時間枠：Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

Time to response is defined as the time from start of treatment to first documentation of response (PR or better).
Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Time to Response Assessed by the Investigator
時間枠：Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

Time to response is defined as the time from start of treatment to first documentation of response (PR or better).
Response was assessed at 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Overall Survival
時間枠：From first dose of study drug until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

Overall survival is defined as the time from the start of treatment to the date of death due to any cause. OS was estimated using the Kaplan-Meier method.
From first dose of study drug until the data cut-off date; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.
Part 2: Change From Baseline in National Comprehensive Cancer Network - Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (NFlymSI-18) Disease Related Symptoms-Physical (DRS-P) Sub-scale Score
時間枠：Baseline and Weeks 4, 12, and 24

The NFlymSI-18 is a patient-reported outcome questionnaire that was developed to measure disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma. The NFLymSI-18 questionnaire includes 18 separate questions about disease symptoms in the last 7 days; participants are asked to respond to each question on a scale from 0 (Not at all) to 4 (Very much). The 18 questions are grouped into 4 subscale scores: "Disease related symptoms - physical," "Disease related symptoms - emotional," "Treatment side effects," and "Function and wellbeing." The Disease Related Symptoms - Physical subscale score ranges from 0 to 36, where higher scores indicate better health-related quality of life (HRQoL).
Baseline and Weeks 4, 12, and 24
Part 2: Change From Baseline in National Comprehensive Cancer Network - Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (NFlymSI-18) Treatment Side-Effects (TSE) Sub-scale Score
時間枠：Baseline and Weeks 4, 12, and 24

The NFlymSI-18 is a patient-reported outcome questionnaire that was developed to measure disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma. The NFLymSI-18 questionnaire includes 18 separate questions about disease symptoms in the last 7 days; participants are asked to respond to each question on a scale from 0 (Not at all) to 4 (Very much). The 18 questions are grouped into 4 subscale scores: "Disease related symptoms - physical," "Disease related symptoms - emotional," "Treatment side effects," and "Function and wellbeing." The Treatment Side-Effects subscale score ranges from 0 to 12, where higher scores indicate better health-related quality of life (HRQoL).
Baseline and Weeks 4, 12, and 24
Part 2: Change From Baseline in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale (VAS) Score
時間枠：Baseline and Weeks 4, 12, and 24

The EQ-5D VAS measures participants' self-rated health status on a scale from 0 to 100, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status.
Baseline and Weeks 4, 12, and 24
Part 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Treatment Discontinuation
時間枠：From first dose of study drug up to 30 days after last dose or the data cut-off date, whichever occurred earlier; maximum duration of treatment in Part 2 was 24.8 months.

An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not.

A serious adverse event is any untoward medical occurrence that, at any dose:

  • Resulted in death
  • Was life-threatening
  • Required hospitalization or prolongation of existing hospitalization.
  • Resulted in disability/incapacity.
  • Was a congenital anomaly/birth defect.
  • Was considered a significant medical adverse event by the investigator or sponsor based on medical judgment.
From first dose of study drug up to 30 days after last dose or the data cut-off date, whichever occurred earlier; maximum duration of treatment in Part 2 was 24.8 months.

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  • スタディディレクター：Study Director、BeOne Medicines

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年9月5日

一次修了 (実際)

2025年7月18日

研究の完了 (推定)

2027年1月31日

試験登録日

最初に提出

2022年7月21日

QC基準を満たした最初の提出物

2022年7月21日

最初の投稿 (実際)

2022年7月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年8月26日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BGB-11417-201
  • CTR20221815 (その他の識別子：ChinaDrugTrials)
  • 2022-500687-35-00 (Ctis)

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BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD 共有時間枠

See plan description

IPD 共有アクセス基準

See plan description

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • CSR

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米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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