CYC065 CDK Inhibitor and Venetoclax Study in Relapsed / Refractory AML or MDS

Status: Active


A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS

Eligibility Criteria

Inclusion Criteria

  • Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
  • ECOG 0-2
  • Adequate renal function
  • Adequate liver function
  • INR <=1.2 in patients not receiving chronic anticoagulation
  • At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
  • Agree to practice effective contraception

Exclusion Criteria

  • AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment
  • Known AML 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: Gautam Borthakur
Phone: 713-794-4823

Trial Objectives and Outline

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. 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 CYC065-03
Secondary IDs NCI-2019-05813 ID NCT04017546