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

AML Clinical Trial

Official title:

A Phase I Combination Study of CYC065 and Venetoclax in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017546
• Other study ID #: CYC065-03
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2019
• Est. completion date: April 5, 2023

Study information

• Verified date: January 2024
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 5, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AML
• MDS
• Myelodysplastic Syndromes

Intervention

Drug:
• CYC065
intravenous infusion
• Venetoclax
oral capsule

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-tumor activity	Number of patients achieving complete remission, partial remission, hematological improvement as evaluated using International Working Group (IWG) response criteria	from the date of first dose of CYC065 to 4 weeks after the last dose of CYC065
Primary	Maximum tolerated dose (MTD)	Number of patients who experience dose-limiting toxicity (DLT)	At the end of cycle 1 (each cycle is 28 days)
Secondary	Pharmacokinetic effect	plasma drug level	At the end of cycle 1 (each cycle is 28 days)
Secondary	Pharmacodynamic effect	MCL-1 level in peripheral white blood cells	At the end of cycle 1 (each cycle is 28 days)