CYC065 CDK Inhibitor and Venetoclax Study in Relapsed / Refractory CLL

Status: Active


A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

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

Locations & Contacts


M D Anderson Cancer Center
Status: Active
Contact: William George Wierda
Phone: 713-563-0291

Trial Objectives and Outline

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 Phase & Type

Trial Phase

Phase I

Trial Type


Lead Organization

Lead Organization
Cyclacel Pharmaceuticals, Inc.

Trial IDs

Primary ID CYC065-02
Secondary IDs NCI-2019-02946 ID NCT03739554