CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic
 Lymphocytic Leukemia (CLL)
This is an open-label, single arm, dose escalation study in patients with relapsed or
 refractory CLL. Treatment will be administered on an outpatient basis and all patients will
 receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination
 with venetoclax. One treatment cycle is 4 weeks.
Inclusion Criteria:

 -  CLL that is relapsed or refractory to BTK inhibitors and is on a stable dose of
 venetoclax

 -  ECOG 0-2

 -  Adequate bone marrow function

 -  Adequate renal function

 -  Adequate liver function

 -  INR <=1.2 in patients not receiving chronic anticoagulation

 -  At least 4 weeks from prior cytotoxic chemotherapy

 -  At least 4 weeks from major surgery

 -  Agree to practice effective contraception

 Exclusion Criteria:

 -  Known CLL involvement in CNS that is symptomatic and active

 -  currently receiving radiotherapy, biological therapy, or any other investigational
 agents

 -  Uncontrolled intercurrent illness

 -  Pregnant or lactating

 -  Known to be HIV-positive

 -  Known active hepatitis B and/or hepatitis C infection