Clinical trial · Interventional

MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL

A Single Arm, Open-label Study of MRD-Guided Zanubrutinib in Combination With Sonrotoclax in Adult Patients With Treatment Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT06367374CI-TRIAL-00076074not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Lymphocytic Leukemia	Chronic Lymphocytic Leukemia	ONTOLOGY_EXACT	0.98
Small Lymphocytic Lymphoma	Small Lymphocytic Lymphoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Sonrotoclax	Drug	—	UNRESOLVED
Zanubrutinib	Drug	Zanubrutinib	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Sonrotoclax Plus Zanubrutinib
description
* Participants will receive from the start of Cycle 1 a standard dose of zanubrutinib twice daily orally for three cycles and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses twice a week until the target dose is reached from Cycle 5 and continuing until the end of Cycle 15 (each cycle is 28 days). Patients with a measurable minimal residual disease (MRD) will receive another 12 cycles of Zanubrutinib in combination with sonrotoclax until their MRD is undetectable. * Interventions: * Drug: Sonrotoclax * Drug: Zanubrutinib
interventionNames
1. Drug: Sonrotoclax
2. Drug: Zanubrutinib

Primary outcomes (1)

measure
4-Year Progressive Free Survival (PFS) Rate
timeFrame
4 years after enrollment
description
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 investigators

Secondary outcomes (8)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Treatment naïve adult patients with diagnosis of CLL/SLL requiring treatment according to iwCLL guidelines 2018
2. Measurable nodal disease by CT/MRI.
3. Adequate hematologic function
4. Adequate hepatic and renal function
5. Eastern Cooperative Oncology Group
6. (ECOG) performance status of 0-2
7. Expected survival period \> 6 months

Exclusion Criteria:

1. Any prior systemic therapy used for treatment of CLL/SLL
2. With history of prolymphocytic leukemia, known or currently suspected Richter's transformation
3. Known central nervous system involvement by leukemia or lymphoma
4. Confirmed progressive multifocal leukoencephalopathy (PML)
5. Severe or debilitating pulmonary disease
6. Clinically significant cardiovascular disease
7. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura requiring treatment
8. History of other malignancies
9. Prior therapy with study drugs within 4 weeks before screening
10. Active fungal, bacterial, and/or viral infection requiring systemic therapy
11. Known allergy to zanubrutinib or sonrotoclax or any pharmaceutical excipients
12. Pregnant or lactating women
13. Vaccinated with live vaccines within 28 days prior to enrollment
14. Serologically positive of human immunodeficiency virus (HIVAb), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
15. History of stroke or intracranial hemorrhage within 6 months
16. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor

References

Publications (0)

Data not yet available

No reference posted for this study.