Mantle Cell LymphomaPhase 1/2NCT05471843
Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 1/2 study testing Sonrotoclax in people with Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma (MCL), run by BeOne Medicines at 65 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma
- What is being tested?
- Sonrotoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 65 sitesin 14 countries
- Study dates
- 5 Sep 2022to 31 Jan 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of MCL
- 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).
- Relapsed/refractory disease
- Presence of measurable disease
- Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Adequate organ function
Who cannot join
- Known central nervous system involvement by lymphoma
- 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.
- Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
- 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.
- Clinically significant cardiovascular disease.
- Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
- Active fungal, bacterial or viral infection requiring systemic treatment.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
65 sites in 14 countries.
65 sites in 14 countries
China23 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
Beijing, Beijing Municipality, 101100
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, 510120
Hainan General Hospital
Haikou, Hainan, 570206
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088
Shandong Cancer Hospital
Jinan, Shandong, 250117
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, 266555
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Henan Cancer Hospital
Zhengzhou, Henan, 450000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Brazil11 sites
Hospital Erasto Gaertner
Curitiba, 81520-060
Hospital Mae de Deus
Porto Alegre, 90110-270
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, 14051-140
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro, 22250-040
Instituto Americas Ensino, Pesquisa E Inovacao
Rio de Janeiro, 22775-001
Hospital Sao Rafael (Rede Dor)
Salvador, 41253-190
Hospital Beneficencia Portuguesa de Sao Paulo
São Paulo, 01323-001
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004
Accamargo Cancer Center
São Paulo, 01508-010
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, 05402-000
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
United States6 sites
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004
Maryland Oncology Hematology, Pa
Columbia, Maryland, 21044-3257
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
Tulane Cancer Center
New Orleans, Louisiana, 70112-2618
France6 sites
Centre Hospitalier Le Mans
Le Mans, 72037
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000
Hopital Pitie Salpetriere Service Hematologie
Paris, 75013
Necker University Hospital
Paris, 75015
Chu Hopital Lyon Sud
PierreBenite, 69495
Chu Tours Hopital Bretonneau Service Pneumologie 2
Tours, 37000
Poland3 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Pratia McM Krakow
Krakow, 30-727
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, 20-090
Turkey (Türkiye)3 sites
Ankara University Medical Faculty
Ankara, 06620
Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, 06620
Vkv American Hospital
Tevikiye, 34365
United Kingdom3 sites
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, OX3 7LE
University College Hospital
London, NW1 2PG
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
Germany2 sites
Universitatsklinikum Koln, Innere Medizin I
Cologne, 50937
Universitatsklinikum Dusseldorf
Düsseldorf, 40225
Israel2 sites
Assuta Ashdod Medical Center
Ashdod, 7747629
Shaare Zedek Medical Center
Jerusalem, 9103102
Spain2 sites
Hospital Universitario Vall Dhebron
Barcelona, 08035
Hospital Universitario Virgen Del Rocio
Seville, 41013
Italy1 site
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014
About this study
Official title: A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
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.
- Conditions
- Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma
- Being tested
- Sonrotoclax
- Keywords
- Mantle Cell Lymphoma, Lymphoma, MCL, Refractory MCL, Refractory Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonrotoclaxDrug
Also called BGB-11417
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Sonrotoclax 160 mg (Daily Ramp-up) | Experimental | 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. Receives: Drug: Sonrotoclax |
| Part 1: Sonrotoclax 320 mg (Daily Ramp-up) | Experimental | 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. Receives: Drug: Sonrotoclax |
| Part 2: Sonrotoclax 320 mg (Daily Ramp-up) | Experimental | 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. Receives: Drug: Sonrotoclax |
| Part 2: Sonrotoclax 320 mg (Twice-weekly Ramp-up) | Experimental | 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. Receives: Drug: Sonrotoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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.
Secondary outcomes (28)
Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Sonrotoclax After a Single Dose
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Target Dose Week 4 Day 1 at predose
Part 1: Overall Response Rate Assessed by the Independent Review Committee (IRC)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
TTR is defined as the time from start of treatment to first documentation of response (PR or better).
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Time to response is defined as the time from start of treatment to first documentation of response (PR or better).
Measured: 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
Time to response is defined as the time from start of treatment to first documentation of response (PR or better).
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start5 Sep 2022
- Primary completion18 Jul 2025
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471843
- Sponsor's protocol ID
- BGB-11417-201
- Other IDs
- 2022-500687-35-00, CTR20221815
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2022
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Wang M, Schuster SJ, Phillips T, Lossos IS, Goy A, Rule S, Hamadani M, Ghosh N, Reeder CB, Barnett E, Bravo MC, Martin P. Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004). J Hematol Oncol. 2017 Nov 2;10(1):171. doi: 10.1186/s13045-017-0537-5.
PubMed 29096668Jain P, Romaguera J, Srour SA, Lee HJ, Hagemeister F, Westin J, Fayad L, Samaniego F, Badillo M, Zhang L, Nastoupil L, Kanagal-Shamanna R, Fowler N, Wang ML. Four-year follow-up of a single arm, phase II clinical trial of ibrutinib with rituximab (IR) in patients with relapsed/refractory mantle cell lymphoma (MCL). Br J Haematol. 2018 Aug;182(3):404-411. doi: 10.1111/bjh.15411. Epub 2018 May 22.
PubMed 29785709Martin P, Maddocks K, Leonard JP, Ruan J, Goy A, Wagner-Johnston N, Rule S, Advani R, Iberri D, Phillips T, Spurgeon S, Kozin E, Noto K, Chen Z, Jurczak W, Auer R, Chmielowska E, Stilgenbauer S, Bloehdorn J, Portell C, Williams ME, Dreyling M, Barr PM, Chen-Kiang S, DiLiberto M, Furman RR, Blum KA. Postibrutinib outcomes in patients with mantle cell lymphoma. Blood. 2016 Mar 24;127(12):1559-63. doi: 10.1182/blood-2015-10-673145. Epub 2016 Jan 13.
PubMed 26764355Eyre TA, Song Y, Hermine O, Shuang Y, Jurczak W, Farias JS, Mahuad C, Ozcan M, Jachimowicz RD, Chen T, Ivanova E, Li X, Man G, Bourquelot P, Vezan R, Wang M. Phase I/II Study of Sonrotoclax (BGB-11417) Monotherapy in Patients With Mantle Cell Lymphoma Previously Treated With Anti-CD20 Therapy and a Bruton Tyrosine Kinase Inhibitor. J Clin Oncol. 2026 Jul 1:JCO2600550. doi: 10.1200/JCO-26-00550. Online ahead of print.
PubMed 42385124