CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

• Status: Unknown status
• Trial end date: 2020-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.
• Collaborator: M.D. Anderson Cancer Center
• Treatments: Venetoclax

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