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

26. srpna 2026 aktualizováno: BeOne Medicines

Jednoramenná, otevřená, multicentrická studie fáze 2 k vyhodnocení účinnosti, bezpečnosti a farmakokinetiky Bcl-2 inhibitoru BGB-11417 u pacientů s relapsem nebo refrakterním lymfomem z plášťových buněk

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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

125

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Sonrotoclax

Administered orally

Ostatní jména:
  • BGB-11417
Experimentální: 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.
Lék: Sonrotoclax

Administered orally

Ostatní jména:
  • BGB-11417
Experimentální: 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.
Lék: Sonrotoclax

Administered orally

Ostatní jména:
  • BGB-11417
Experimentální: 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.
Lék: Sonrotoclax

Administered orally

Ostatní jména:
  • BGB-11417

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Sonrotoclax After a Single Dose
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

BeOne Medicines

Vyšetřovatelé

  • Ředitel studie: Study Director, BeOne Medicines

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. září 2022

Primární dokončení (Aktuální)

18. července 2025

Dokončení studie (Odhadovaný)

31. ledna 2027

Termíny zápisu do studia

První předloženo

21. července 2022

První předloženo, které splnilo kritéria kontroly kvality

21. července 2022

První zveřejněno (Aktuální)

25. července 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BGB-11417-201
  • CTR20221815 (Jiný identifikátor: ChinaDrugTrials)
  • 2022-500687-35-00 (Ctis)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

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.

Časový rámec sdílení IPD

See plan description

Kritéria přístupu pro sdílení IPD

See plan description

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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