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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

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