MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

May 30, 2024

Primary Completion Date

February 28, 2030

Study Completion Date

July 30, 2030

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Sonrotoclax

"Participants receive zanubrutinib orally 160mg bid from start of Cycle 1, and in combination with sonrotoclax (SZ) from Cycle 4 onwards at increasing doses until 320mg daily target dose is reached and continuing for at least 12 cycles (each cycle is 28 days).~Participants with uMRD and PR/CR by the end of Cycle 15 will stop SZ treatment, others will continue to receive SZ for another 12 cycles and stop SZ if uMRD and PR/CR.~Participants will receive sonrotoclax up to 2 years, and receive zanubrutinib for those with MRD-positive by then."

DRUG

Zanubrutinib

"Participants receive zanubrutinib orally 160mg bid from start of Cycle 1,Participants with uMRD and PR/CR by the end of Cycle 15 will stop SZ treatment, others will continue to receive SZ for another 12 cycles and stop SZ if uMRD and PR/CR.~Participants will receive sonrotoclax up to 2 years, and receive zanubrutinib for those with MRD-positive by then."

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER