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CDK Inhibitor

CYC065 for Chronic Lymphocytic Leukemia

Phase 1
Waitlist Available
Research Sponsored by Cyclacel Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat CLL that has come back or is not responding to treatment.

Eligible Conditions
  • Chronic Lymphocytic Leukemia (CLL)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients who experience dose-limiting toxicity (DLT)
Secondary outcome measures
Pharmacodynamic effect
Pharmacokinetic effect
Other outcome measures
Anti-tumor activity

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: CYC065 and venetoclaxExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
CYC065
2019
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Cyclacel Pharmaceuticals, Inc.Lead Sponsor
19 Previous Clinical Trials
2,474 Total Patients Enrolled
Judy Chiao, MDStudy DirectorCyclacel Pharmaceuticals, Inc.
1 Previous Clinical Trials
50 Total Patients Enrolled
Mark Kirschbaum, MDStudy DirectorCyclacel Pharmaceuticals, Inc.
2 Previous Clinical Trials
38 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to recruitment of participants?

"This investigation has concluded participant recruitment, having been initially posted on January 25th 2019. For those seeking alternative trials, there are currently 1516 clinical studies for leukemia/lymphoid and 222 investigations involving CYC065 which remain open to patients."

Answered by AI

Are there any other explorations that have involved CYC065?

"The first investigation into CYC065 was conducted in 2014 at the M.D Anderson Cancer Center, and since then a total of 51 trials have been concluded thus far. Currently 222 studies are underway with numerous sites located in Charlotte, North carolina."

Answered by AI

What is the scale of this clinical trial in terms of participants?

"At this moment, recruitment for this trial has been suspended. It was first published on January 25th 2019 and the last update came out April 22nd 2022. If you are seeking other studies to take part in, there are presently 1516 clinical trials enrolling patients with leukemia or lymphoid cancer as well as 222 studies that require CYC065 participants."

Answered by AI

What is the regulatory status of CYC065?

"Owing to the limited data and research surrounding CYC065, our team at Power rated its safety as a 1 on a scale from 1-3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
2019. "CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03739554.
~1 spots leftby Apr 2025
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