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)

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

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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03739554.

University of Maryland/Greenebaum Cancer Center

Status: Active

Contact: Nicole M. Glynn-Cunningham

Phone: 410-328-7996

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.

Trial PhasePhase I

Trial Typetreatment

Lead OrganizationCyclacel Pharmaceuticals, Inc.

Description