CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

NCT ID: NCT03739554

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2023-04-27

Brief Summary

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

Detailed 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.

Conditions

Relapsed or Refractory Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CYC065 and venetoclax

CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15 after the venetoclax ramp-up schedule is completed. Venetoclax will be taken daily at a dose that is deemed safe and tolerable after the ramp-up schedule. One cycle will be 28 days or 4 weeks.

Group Type: EXPERIMENTAL

CYC065

Intervention Type: DRUG

intravenous infusion

Venetoclax

Intervention Type: DRUG

oral capsule

Interventions

CYC065

intravenous infusion

Intervention Type: DRUG

Venetoclax

oral capsule

Intervention Type: DRUG

Other Intervention Names

ABT-199

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyclacel Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Kirschbaum, MD

Role: STUDY_DIRECTOR

Cyclacel Pharmaceuticals, Inc.

Locations

Investigational Site

Baltimore, Maryland, United States

Investigational Site

Charlotte, North Carolina, United States

Investigational Site

Houston, Texas, United States

Countries

United States

Other Identifiers

CYC065-02

Identifier Type: -

Identifier Source: org_study_id