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

keskiviikko 26. elokuuta 2026 päivittänyt: BeOne Medicines

Yksihaarainen, avoin, monikeskustutkimus, vaiheen 2 tutkimus Bcl-2-inhibiittorin BGB-11417 tehon, turvallisuuden ja farmakokinetiikan arvioimiseksi potilailla, joilla on uusiutunut tai refraktaarinen vaippasolulymfooma

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.

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

125

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Lääke: Sonrotoclax

Administered orally

Muut nimet:
  • BGB-11417
Kokeellinen: 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.
Lääke: Sonrotoclax

Administered orally

Muut nimet:
  • BGB-11417
Kokeellinen: 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.
Lääke: Sonrotoclax

Administered orally

Muut nimet:
  • BGB-11417
Kokeellinen: 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.
Lääke: Sonrotoclax

Administered orally

Muut nimet:
  • BGB-11417

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Sonrotoclax After a Single Dose
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Sponsori

BeOne Medicines

Tutkijat

  • Opintojohtaja: Study Director, BeOne Medicines

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Opintojen ennätyspäivät

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Opiskelun aloitus (Todellinen)

Maanantai 5. syyskuuta 2022

Ensisijainen valmistuminen (Todellinen)

Perjantai 18. heinäkuuta 2025

Opintojen valmistuminen (Arvioitu)

Sunnuntai 31. tammikuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 21. heinäkuuta 2022

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Torstai 21. heinäkuuta 2022

Ensimmäinen Lähetetty (Todellinen)

Maanantai 25. heinäkuuta 2022

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 22. syyskuuta 2026

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Keskiviikko 26. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

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Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • BGB-11417-201
  • CTR20221815 (Muu tunniste: ChinaDrugTrials)
  • 2022-500687-35-00 (Ctis)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

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IPD-suunnitelman kuvaus

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.

IPD-jaon aikakehys

See plan description

IPD-jaon käyttöoikeuskriteerit

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IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • CSR

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