- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03739554
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
January 24, 2024 updated by: Cyclacel Pharmaceuticals, Inc.
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21201
- Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Investigational Site
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Texas
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Houston, Texas, United States, 77030
- Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
intravenous infusion
oral capsule
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who experience dose-limiting toxicity (DLT)
Time Frame: At the end of cycle 1 (each cycle is 28 days)
|
At the end of cycle 1 (each cycle is 28 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacodynamic effect
Time Frame: At the end of cycle 1 (each cycle is 28 days)
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MCL-1 level in peripheral white blood cells
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At the end of cycle 1 (each cycle is 28 days)
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Pharmacokinetic effect
Time Frame: At the end of cycle 1 (each cycle is 28 days)
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Plasma drug level
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At the end of cycle 1 (each cycle is 28 days)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-tumor activity
Time Frame: From the date of first dose of CYC065 to 4 weeks after the last dose of CYC065
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Response assessed by investigators based on International Workshop for CLL criteria or International Working Group criteria for patients with small lymphocytic lymphoma.
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From the date of first dose of CYC065 to 4 weeks after the last dose of CYC065
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mark Kirschbaum, MD, Cyclacel Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2019
Primary Completion (Actual)
November 15, 2022
Study Completion (Actual)
April 27, 2023
Study Registration Dates
First Submitted
October 1, 2018
First Submitted That Met QC Criteria
November 9, 2018
First Posted (Actual)
November 14, 2018
Study Record Updates
Last Update Posted (Estimated)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Leukemia, B-Cell
- Chronic Disease
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Antineoplastic Agents
- Venetoclax
Other Study ID Numbers
- CYC065-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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