Status:
COMPLETED
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS
Lead Sponsor:
Cyclacel Pharmaceuticals, Inc.
Conditions:
AML
MDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04017546
Start Date
August 2 2019
End Date
April 5 2023
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030