Relapsed or Refractory Chronic Lymphocytic LeukemiaPhase 1NCT03739554
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
A Phase 1 study testing CYC065 and Venetoclax in people with Relapsed or Refractory Chronic Lymphocytic Leukemia, run by Cyclacel Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Chronic Lymphocytic Leukemia
- What is being tested?
- CYC065 and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jan 2019to 27 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- At least 4 weeks from prior cytotoxic chemotherapy
- At least 4 weeks from major surgery
- Agree to practice effective contraception
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Investigational Site
Baltimore, Maryland, 21201
Investigational Site
Charlotte, North Carolina, 28204
Investigational Site
Houston, Texas, 77030
About this study
Official title: 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)
Read the 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.
- Being tested
- CYC065, Venetoclax
- Keywords
- CYC065, CDK2/9, venetoclax, BCL-2, MCL-1, Relapsed, Refractory, chronic lymphocytic leukemia, small lymphocytic lymphoma
- Medical subject headings
- Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYC065Drug
intravenous infusion
VenetoclaxDrug
Also called ABT-199
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CYC065; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experience dose-limiting toxicity (DLT)
Measured: At the end of cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
Pharmacokinetic effect
Plasma drug level
Measured: At the end of cycle 1 (each cycle is 28 days)
Pharmacodynamic effect
MCL-1 level in peripheral white blood cells
Measured: At the end of cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start25 Jan 2019
- Primary completion15 Nov 2022
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kirschbaum, MD, Study director, Cyclacel Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739554
- Sponsor's protocol ID
- CYC065-02
- Status last verified
- Jan 2024
- First submitted
- 1 Oct 2018
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT03739554
- Acronym / sponsor ID
- CYC065-02
- Keywords
- CYC065, CDK2/9, venetoclax, BCL-2, MCL-1, Relapsed, Refractory, chronic lymphocytic leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CYC065 and venetoclax | Experimental | Drug: CYC065, Drug: VenetoclaxCYC065 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYC065intravenous infusion | Drug | CYC065 and venetoclax |
| VenetoclaxAlso: ABT-199oral capsule | Drug | CYC065 and venetoclax |
Primary outcome
Number of patients who experience dose-limiting toxicity (DLT)
Time frame: At the end of cycle 1 (each cycle is 28 days)
2 secondary outcomes
Pharmacokinetic effect
Time frame: At the end of cycle 1 (each cycle is 28 days)
Pharmacodynamic effect
Time frame: At the end of cycle 1 (each cycle is 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Kirschbaum, MD study director
Cyclacel Pharmaceuticals, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYC065 and Venetoclax in people with Relapsed or Refractory Chronic Lymphocytic Leukemia, run by Cyclacel Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experience dose-limiting toxicity (DLT) (time frame: At the end of cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.