Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Pratia MCM Krakow
Krakow, Poland
Safety and Tolerability
Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy
Time frame: Up to 3 years
Overall Response Rate
Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome
Time frame: Up to 3 years
Duration of Response
Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per applicable response criteria
Time frame: Up to 3 years
Progression Free Survival
Number of Participants Without Disease Progression per iwCLL guidelines for CLL \& Lugano Classification for NHL
Time frame: Up to 3 years
Assessment of pharmacokinetics (PK) of VIP152
Maximum observed drug concentration in measured administration (Cmax) of VIP152
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1
Time To Next Treatment
time from first dose to the initiation of next dose or death
Time frame: Up to 3 years
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