A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia

Conditions

treatment-naive Chronic Lymphocytic Leukemia

Brief summary

• PFS, defined as time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.

Detailed description

• uMRD4 rate defined as the proportion of patients that achieved uMRD4 measured in both PB and BMA at the PTFU1 Visit based on next-generation sequencing (NGS [clonoSEQ]), • PFS as determined by IRC in high-risk patients that have unmutated IGHV and/or TP53 aberrations (del(17p) present and/or TP53 mutated), • OS, defined as time from the date of randomization to the date of death due to any cause, • ORR defined as the proportion of patients with a CR, CRi, nodular partial response (nPR), or partial response (PR) per the IRC assessment, • uMRD5 rate defined as the proportion of patients that achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS (clonoSEQ), • Adverse events (AEs), adverse events of clinical interest (AECIs), serious adverse events (SAEs), changes from baseline in clinical laboratory tests, physical examinations, and vital signs, • PFS determined by investigator assessment, • Overall CRR determined by IRC and by investigator assessment., • ORR determined by investigator assessment, • Duration of response (DOR; determined by both IRC and investigator assessment) defined as the time from first qualifying response (CR, CRi, nPR, or PR) until disease progression or death, • Time to next treatment (TTNT) defined as the time from randomization to the start of next treatment for CLL, • Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden, and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGVenclyxto 100 mg film-coated tablets

DRUGBGB-11417

DRUGCalquence 100 mg film-coated tablets

DRUGZanubrutinib

DRUGVenclyxto 10 mg film-coated tablets

DRUGVenclyxto 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• PFS, defined as time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.	—

Secondary

Measure	Time frame
• uMRD4 rate defined as the proportion of patients that achieved uMRD4 measured in both PB and BMA at the PTFU1 Visit based on next-generation sequencing (NGS [clonoSEQ]), • PFS as determined by IRC in high-risk patients that have unmutated IGHV and/or TP53 aberrations (del(17p) present and/or TP53 mutated), • OS, defined as time from the date of randomization to the date of death due to any cause, • ORR defined as the proportion of patients with a CR, CRi, nodular partial response (nPR), or partial response (PR) per the IRC assessment, • uMRD5 rate defined as the proportion of patients that achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS (clonoSEQ), • Adverse events (AEs), adverse events of clinical interest (AECIs), serious adverse events (SAEs), changes from baseline in clinical laboratory tests, physical examinations, and vital signs, • PFS determined by investigator assessment, • Overall CRR determined by IRC and by investigator assessment., • ORR determ	—

Measure

Time frame

• uMRD4 rate defined as the proportion of patients that achieved uMRD4 measured in both PB and BMA at the PTFU1 Visit based on next-generation sequencing (NGS [clonoSEQ]), • PFS as determined by IRC in high-risk patients that have unmutated IGHV and/or TP53 aberrations (del(17p) present and/or TP53 mutated), • OS, defined as time from the date of randomization to the date of death due to any cause, • ORR defined as the proportion of patients with a CR, CRi, nodular partial response (nPR), or partial response (PR) per the IRC assessment, • uMRD5 rate defined as the proportion of patients that achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS (clonoSEQ), • Adverse events (AEs), adverse events of clinical interest (AECIs), serious adverse events (SAEs), changes from baseline in clinical laboratory tests, physical examinations, and vital signs, • PFS determined by investigator assessment, • Overall CRR determined by IRC and by investigator assessment., • ORR determ

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Outcome results

None listed