CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

Phase 1

Completed

• Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia
• Interventions: Drug: CYC065; Drug: Venetoclax

• Registration Number: NCT03739554
• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Study Start: 2019-01-25
• Primary Completion: 2022-11-15
• Study Completion: 2023-04-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CYC065 and venetoclax	CYC065	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.
CYC065 and venetoclax	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.

Primary Outcome Measures

Name	Time	Method
Number of patients who experience dose-limiting toxicity (DLT)	At the end of cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic effect	At the end of cycle 1 (each cycle is 28 days)	Plasma drug level
Pharmacodynamic effect	At the end of cycle 1 (each cycle is 28 days)	MCL-1 level in peripheral white blood cells

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Houston, Texas, United States