CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

Completed · Phase 1

Conditions studied: Relapsed or Refractory Chronic Lymphocytic Leukemia

In brief

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

Key facts

Study ID

NCT03739554

Run by

Cyclacel Pharmaceuticals, Inc.

People needed

5

Starts

2019-01-25

Expected to finish

2023-04-27

Last updated by the study team

2024-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigational Site — Baltimore, Maryland, United States
• Investigational Site — Charlotte, North Carolina, United States
• Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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