CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

NCT03739554 | Completed Phase 1 FDA Drug

• 1 other identifier: CYC065-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Relapsed or Refractory Chronic Lymphocytic Leukemia

Keywords

CYC065; CDK2/9; venetoclax; BCL-2; MCL-1; Relapsed; Refractory; chronic lymphocytic leukemia; small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of patients who experience dose-limiting toxicity (DLT)

  At the end of cycle 1 (each cycle is 28 days)

Secondary Outcomes (2)

• Pharmacokinetic effect

  At the end of cycle 1 (each cycle is 28 days)

• Pharmacodynamic effect

  At the end of cycle 1 (each cycle is 28 days)

Other Outcomes (1)

• Anti-tumor activity

  From the date of first dose of CYC065 to 4 weeks after the last dose of CYC065

Study Arms (1)

CYC065 and venetoclax

EXPERIMENTAL

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.

Drug: CYC065; Drug: Venetoclax

Interventions

CYC065 DRUG

intravenous infusion

CYC065 and venetoclax

Venetoclax DRUG

oral capsule

Also known as: ABT-199

CYC065 and venetoclax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead

Study Sites (3)

Investigational Site

Baltimore, Maryland, 21201, United States

Location

Investigational Site

Charlotte, North Carolina, 28204, United States

Location

Investigational Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Recurrence; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

CYC065; venetoclax

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease

Study Officials

• Mark Kirschbaum, MD

  Cyclacel Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three to 6 patients will be entered at a given CYC065 dose level. Dose escalation will be 33% until one out of 3 patients experienced a DLT at a given dose level. Dose escalation will continue at 25% if no additional DLT is observed; otherwise, dose escalation will be stopped. At least 6 patients will be treated at RD.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: November 14, 2018
• Study Start: January 25, 2019
• Primary Completion: November 15, 2022
• Study Completion: April 27, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)