Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
Noncovalent Bruton tyrosine kinase inhibitor, Bruton tyrosine kinase-targeted protein degrader
Brief summary
The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Interventions
DRUGBGB-16673
BGB-16673 will be administered orally
DRUGPirtobrutinib
Pirtobrutinib will be administered orally
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria * Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi. * Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
Exclusion criteria
* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation. * History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention * History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug * Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi). * Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) per Independent Review Committee (IRC) | Up to approximately 3 years | PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 3 years | OS is defined as the time from the date of randomization to the date of death due to any cause. |
| PFS per Investigator (INV) | Up to approximately 3 years | PFS per INV is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by investigator using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with CLL and Lugano classification for participants with SLL. |
| Overall Response Rate (ORR) per IRC and INV | Up to approximately 3 years | ORR is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, or partial response, as assessed by the investigator and IRC using modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL. |
| Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV | Up to approximately 3 years | The rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, partial response, or PR-L. |
| Duration of Response (DOR) per IRC and INV | Up to approximately 3 years | DOR is defined as the time from initial response to disease progression or death, whichever occurs first. |
| Time to Next Anti-CLL/SLL Treatment (TTNT) | Up to approximately 3 years | TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment. |
| Number of Participants with Adverse Events (AEs) | Up to approximately 3 years | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities. |
| Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409 | Baseline and up to approximately 3 years | EORTC IL409 consists of a set of 19 questions derived from the EORTC quality of life questionnaire core 30 (QLQ-C30) and its CLL module CLL17. The EORTC IL409 includes questions on global health status (GHS)/quality of life, physical functioning, role functioning, physical condition/fatigue, and symptom burden.Higher scores in GHS and functional scales and lower scores in symptom scales indicate better health-related quality of life. |
Countries
Australia, Austria, Belgium, Brazil, France, Germany, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed