CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

Relapsed or Refractory Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739554
• Other study ID #: CYC065-02
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2019
• Est. completion date: April 27, 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 Chronic Lymphocytic Leukemia (CLL)

Description:

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory CLL. 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: 5
• Est. completion date: April 27, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Relapsed or Refractory Chronic Lymphocytic Leukemia

Intervention

Drug:
• CYC065
intravenous infusion
• Venetoclax
oral capsule

Locations

Country	Name	City	State
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-tumor activity	Response assessed by investigators based on International Workshop for CLL criteria or International Working Group criteria for patients with small lymphocytic lymphoma.	From the date of first dose of CYC065 to 4 weeks after the last dose of CYC065
Primary	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)