To hear about similar clinical trials, please enter your email below
Trial Title:
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID:
NCT06637501
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Zanubrutinib
Conditions: Keywords:
CLL
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sonrotoclax
Description:
Administered orally
Arm group label:
Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib
Other name:
BGB-11417
Intervention type:
Drug
Intervention name:
Zanubrutinib
Description:
Administered orally
Arm group label:
Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib
Arm group label:
Arm B: Monotherapy: Zanubrutinib
Other name:
BRUKINSA
Other name:
BGB-3111
Summary:
The purpose of this study is to support the registration plan of sonrotoclax plus
zanubrutinib treatment in participants with previously untreated CLL. This study is
designed to assess the contribution of sonrotoclax to the efficacy outcome of the
combination of zanubrutinib and sonrotoclax.
Detailed description:
This study will test how effective and safe sonrotoclax plus zanubrutinib treatment
compared with zanubrutinib alone in participants with previously untreated chronic
lymphocytic leukemia (CLL).
The main goals of the study are to determine how many participants may no longer have
evidence of cancer or have some improvement in the signs and symptoms of cancer after
treatment and to determine what adverse events, or side effects, patients might
experience.
Sonrotoclax is an experimental drug that works by blocking a protein called B-cell
lymphoma-2 (Bcl-2). This protein helps certain types of blood tumor cells to survive and
grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and
helps them die. This can lead to improvements in patients with CLL disease.
Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's
tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells.
Zanubrutinib has received approval in over 65 countries/regions worldwide for the
treatment of adult participants with B cell malignancies, including CLL.
The study will enroll approximately 87 participants who will be randomly assigned by a
computer program to receive one of the following treatments: sonrotoclax + zanubrutinib
or zanubrutinib.
The study will take place at multiple centers worldwide. The overall time to participate
in this study is approximately 5 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
2. CLL requiring treatment as per pre-defined criteria.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
4. Measurable disease by CT/MRI.
5. Adequate marrow function.
6. Adequate liver function as indicated by aspartate aminotransferase (AST) alanine
aminotransferase (ALT) and serum total bilirubin.
7. Adequate renal function.
8. Life expectancy > 6 months.
9. Signed informed consent and able to comply with the study protocol in the
investigator's judgment.
10. Women of childbearing potential must be willing to use a highly effective method of
birth control for the duration of the study and for ≥ 90 days after the last dose of
study drug.
Exclusion Criteria:
1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's
transformation
2. Known central nervous system involvement
3. Received previous systemic treatment for CLL
4. Clinically significant cardiovascular disease
5. Severe or debilitating pulmonary disease
6. History of prior malignancy
7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
8. Positive HIV serology (HIVAb) status or serologic status reflecting active hepatitis
B or C infection
9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring
treatment
10. History of severe bleeding disorder such as hemophilia A, hemophilia B, von
Willebrand disease, or history of spontaneous bleeding requiring blood transfusion
or other medical intervention
11. History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of
study treatment
12. Unable to swallow capsules or tablets or diseases significantly affecting GI
function
13. Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
14. Use of investigational agents within the last 4 weeks before screening
15. Pregnant and lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
June 2030
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06637501
