A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.
This is an open label Phase 2 clinical study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with R/R CLL. VEN and R will be administered per standard of care. Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Zandelisib taken orally for 7 days of each 28 day cycle
Rituximab IV for 6 cycles
Orally - Ramp up weeks 1-5
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Stony Brook University
Stony Brook, New York, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, United States
To determine the uMRD rate in PB and BM by flow cytometry
measured by 8-color flow cytometry with a quantitative lower limit of detection of at least 10-4 (1 in 10,000 cells).
Time frame: 2 year
ORR
The ORR will be measured by the proportion of subjects having achieved a CR/CRi (CR with incomplete recovery in BM) or partial response (PR) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (2018)
Time frame: 2 years
Progression Free Survival
PFS will be measured as the time from first dose date until progression according the iwCLL criteria or death from any cause.
Time frame: 5 years
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