Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

CLL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073821
• Other study ID #: BGB-11417-301
• Status: Recruiting
• Phase: Phase 3
• Start date: November 11, 2023
• Est. completion date: December 2032

Study information

• Verified date: April 2024
• Source: BeiGene
• Contact: Study Director
• Phone: 1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

Description:

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong participant life and control disease-related symptoms. In this study, participants with CLL, without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL. The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received venetoclax plus obinutuzumab versus sonrotoclax plus zanubrutinib. Approximately 640 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: December 2032
• Est. primary completion date: February 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
• Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
• Measurable disease by Computer Tomography/Magnetic Resonance Imaging
• Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
• Adequate renal function as defined as creatinine clearance = 50 milliliters per minute

Exclusion Criteria:

• Previous systemic treatment for CLL
• Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
• Known central nervous system involvement
• History of confirmed progressive multifocal leukoencephalopathy (PML)
• Uncontrolled hypertension Note: Other protocol defined criteria may apply

Related Conditions & MeSH terms

• CLL
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Sonrotoclax
Administered orally
• Zanubrutinib
Administered orally
• Venetoclax
Administered orally
• Obinutuzumab
Administered intravenously

Locations

Country	Name	City	State
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	Sunshine Coast Hospital and Health Service	Birtinya	Queensland
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Monash Health	Clayton	Victoria
Australia	St Vincents Hospital Melbourne	Fitzroy	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Cabrini Hospital Malvern	Malvern	Victoria
Australia	Peter Maccallum Cancer Centre	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Hollywood Private Hospital	Nedlands	Western Australia
Australia	Genesiscare North Shore	St Leonards	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Canada	Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre	Greenfiled Park	Quebec
Canada	Chu de Quebec Universite Laval	Quebec
Canada	Ciusss de Lestrie Chus	Sherbrooke	Quebec
Korea, Republic of	Pusan National University Hospital	Busan	Busan Gwang'yeogsi
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasungun	Jeonranamdo
Korea, Republic of	Seoul National University Bundang Hospital	Seongnamsi	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, Seoul St Marys Hospital	Seoul	Seoul Teugbyeolsi
New Zealand	Auckland City Hospital	Auckland
New Zealand	Health New Zealand Canterbury	Christchurch
New Zealand	North Shore Hospital	Takapuna
New Zealand	Tauranga Hospital	Tauranga
New Zealand	Wellington Regional Hospital (Ccdhb)	Wellington
Puerto Rico	Auxilio Mutuo Cancer Center	San Juan
United States	Alaska Oncologyand Hematology, Llc	Anchorage	Alaska
United States	St Vincent Frontier Cancer Center	Billings	Montana
United States	Mission Cancer and Blood	Des Moines	Iowa
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Lumi Research	Kingwood	Texas
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	Norton Cancer Institute Pavilion	Louisville	Kentucky
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Clinical Research Alliance, Inc	Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Korea, Republic of,  New Zealand,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by independent review committee (IRC)	Up to approximately 9 years
Secondary	Complete Response Rate (CRR)	CRR is defined as the percentage of participants that achieved best response of complete response (CR)/ complete response with incomplete hematopoietic recovery (CRi), determined by IRC.	Up to approximately 9 years
Secondary	Rates of Undetectable Measurable Residual Disease	Undetectable measurable residual disease uMRD4 rate at the first Post- Treatment Follow-up (PTFU 1) Visit will be based on next-generation sequencing.	Up to approximately 9 years
Secondary	Overall Survival (OS)	OS is defined as time from the date of enrollment to the date of death because of any cause	Up to approximately 9 years
Secondary	PFS by Investigator Assessment	FS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by investigator assessment	Up to approximately 9 years
Secondary	CRR by Investigator Assessment	CRR is defined as the percentage of participants that achieved best response of complete response (CR)/ complete response with incomplete hematopoietic recovery (CRi), determined by Investigator Assessment	Up to approximately 9 years
Secondary	Rates of uMRD4 Based on Flow-Cytometry	The overall uMRD4 rate is defined as the proportion of participants who achieve uMRD status in peripheral blood before disease progression or start of new anti-CLL treatment (whichever is earlier), based on flow cytometry.	Up to approximately 9 years
Secondary	Overall Response Rate (ORR) Determined by IRC and Investigator Assessment	ORR is defined as the percentage of participants who achieve a response (CR, CRi, nodular partial remission (nPR), partial response (PR), and partial response with lymphocytosis [PR-L]), before disease progression or start of new anti-CLL treatment (whichever is earlier).	Up to approximately 9 years
Secondary	Duration of Response (DOR) by IRC and Investigator Assessment	Duration of response (DOR) is defined as the time from first qualifying response PR, PR-L, CR, or CRi) until CLL progression or death.	Up to approximately 9 years
Secondary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to approximately 9 years
Secondary	The Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	Global health status (GHS)/qualify of life (QoL) and physical functioning measured by EORTC QLQ-C30 The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).	Up to approximately 9 years
Secondary	HRQoL) as Assessed by EORTC QLQ-C30 CLL Module Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17)	The symptom burden and physical condition/fatigue will be measured by QLQ-CLL17.; EORTC QLQ-CLL17 comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning.; The EORTC QLQ-CLL17 will be scored according to the EORTC QLQ-C30 Scoring Manual. An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales, each of the functional scales, and the global measure of health status scale. Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity	Up to approximately 9 years
Secondary	European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L)	Mean change from baseline in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.	Up to approximately 9 years