Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
- Conditions
- Mantle Cell LymphomaRefractory Mantle Cell Lymphoma (MCL)Relapsed Mantle Cell Lymphoma
- Interventions
- Registration Number
- NCT05471843
- Lead Sponsor
- BeiGene
- Brief Summary
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm BGB-11417 Participants will receive sonrotoclax
- Primary Outcome Measures
Name Time Method Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) Up to 1 Year Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. Up to 5 Years Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events Up to 5 Years Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) Up to 4 Years Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification
- Secondary Outcome Measures
Name Time Method Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC) Up to 2 Years Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax) Up to 2 Years Part 1: Single Dose Time to reach Cmax (Tmax) Up to 2 Years Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC) Up to 2 Years Part 1: Steady State Maximum Observed Plasma Concentration (Cmax) Up to 2 Years Part 1: Steady State Trough Plasma Concentration (CTrough) Up to 2 Years Part 1: Steady State Time to reach Cmax (Tmax) Up to 2 Years Overall Response Rate (ORR) as assessed by investigator Up to 4 Years Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification
Duration of Response (DOR) as assessed by investigator and IRC Up to 4 Years 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 occurs first
Progression Free Survival (PFS) as assessed by investigator and IRC Up to 4 Years 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 occurs first.
Time to Response (TTR) as assessed by investigator and IRC Up to 4 Years TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better
Overall Survival (OS) Up to 4 Years Defined as time from the start of treatment to the date of death due to any cause
Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. Up to 4 Years Part 2: Number of participants with clinically significant changes from baseline in vital signs Up to 4 Years Vital signs include blood pressure and pulse rate
Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values Up to 4 Years Laboratory values include hematology, and clinical chemistry
Part 2: Number of Participants With Clinically Significant Physical Examination Findings Up to 4 Years A Physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Part 2: Participant Reported Outcomes as measured by NFLymSI-18 Up to 4 Years The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.
Part 2: Participant Reported Outcomes as measured by EQ-5D-5L questionnaires Up to 4 Years The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Trial Locations
- Locations (104)
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
🇧🇷Ribeirao Preto, Brazil
Oncoclinicas Rio de Janeiro Sa
🇧🇷Rio de Janeiro, Brazil
Churchill Hospital Oxford University Hospital Nhs Trust
🇬🇧Headington, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Wirral, United Kingdom
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
AZ DELTA
🇧🇪Roeselare, Belgium
Hospital Erasto Gaertner
🇧🇷Curitiba, Brazil
Hospital Mae de Deus
🇧🇷Porto Alegre, Brazil
Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
🇹🇷Ankara, Turkey
Gazi University
🇹🇷Ankara, Turkey
Ondokuz Mayis University Medicine Faculty Hospital
🇹🇷Atakum Samsun, Turkey
Bagcilar Medipol Mega Hospital
🇹🇷Istanbul, Turkey
Vkv American Hospital
🇹🇷Istanbul, Turkey
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Erciyes University School of Medicine
🇹🇷Kayseri, Turkey
Kocaeli Universitesi Tip Fakultesi
🇹🇷Kocaeli, Turkey
The Christie Hospital
🇬🇧Greater Manchester, United Kingdom
Az Sint Jan Brugge
🇧🇪Brugge, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
University of Alabama At Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
University Hospitals Leuven
🇧🇪Leuven, Belgium
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Des Moines Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Tulane Cancer Center
🇺🇸New Orleans, Louisiana, United States
Luminis Health Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Maryland Oncology Hematology, Pa
🇺🇸Columbia, Maryland, United States
University of Missouri Hospital, Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Nebraska Cancer Specialists
🇺🇸Grand Island, Nebraska, United States
Dartmouth Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Novant Health Hematology Charlotte
🇺🇸Charlotte, North Carolina, United States
The University of Texas Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
Hospital Aleman
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Instituto Americas Ensino, Pesquisa E Inovacao
🇧🇷Rio de Janeiro, Brazil
Hospital Sao Rafael (Rede Dor)
🇧🇷Salvador, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
🇧🇷Sao Paulo, Brazil
Hospital Beneficencia Portuguesa de Sao Paulo
🇧🇷Sao Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
🇧🇷Sao Paulo, Brazil
Accamargo Cancer Center
🇧🇷Sao Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
🇧🇷Sao Paulo, Brazil
Qeii Health Science Center
🇨🇦Halifax, Nova Scotia, Canada
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
🇨🇳Hefei, Anhui, China
China Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
🇨🇳Beijing, Beijing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital Huifu Branch
🇨🇳Guangzhou, Guangdong, China
Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Cancer Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
🇨🇳Nanchang, Jiangxi, China
Jiangxi Province Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Branch West Coast
🇨🇳Qingdao, Shandong, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
The First Peoples Hospital of Kashgar
🇨🇳Kashgar, Xinjiang, China
Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
🇫🇷Nantes Cedex, France
Hopital Pitie Salpetriere Service Hematologie
🇫🇷Paris, France
Necker University Hospital
🇫🇷Paris, France
Chu Hopital Lyon Sud
🇫🇷PierreBenite, France
Chu Tours Hopital Bretonneau Service Pneumologie
🇫🇷Tours, France
Universitatsklinikum Dusseldorf
🇩🇪Dusseldorf, Germany
Universitatsklinikum Essen (Aor)
🇩🇪Essen, Germany
Universitatsklinikum Schleswig Holstein, Campus Kiel
🇩🇪Kiel, Germany
Universitatsklinikum Koln, Innere Medizin I
🇩🇪Koeln, Germany
Assuta Ashdod Medical Center
🇮🇱Ashdod, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Hadassah En Karem Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Sheba Medical Center
🇮🇱Tel Aviv, Israel
Sourasky Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Irccs Istituto Tumori Giovanni Paolo Ii
🇮🇹Bari, Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
🇮🇹Bologna, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
🇮🇹Brescia, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
🇮🇹Meldola, Italy
Aou Maggiore Della Carita
🇮🇹Novara, Italy
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Pratia McM Krakow
🇵🇱Krakow, Poland
Uniwersytecki Szpital Kliniczny Nr W Lublinie
🇵🇱Lublin, Poland
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
🇵🇱Warszawa, Poland
Auxilio Mutuo Cancer Center
🇵🇷San Juan, Puerto Rico
Hospital Universitario Vall Dhebron
🇪🇸Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain