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

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

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

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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04017546.

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 PhasePhase I

Trial Typetreatment

Lead OrganizationCyclacel Pharmaceuticals, Inc.

Description