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
- 125
- 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 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).
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.
Trial Locations
- Locations (104)
University of Alabama At Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Medstar Georgetown University Hospital
🇺🇸Washington D.C., District of Columbia, United States
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
Scroll for more (94 remaining)University of Alabama At Birmingham Hospital🇺🇸Birmingham, Alabama, United States