CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Ref... | NCT03739554

Studies
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

NCT03739554

Sponsor

Cyclacel Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Jan 25, 2024Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions

CYC065
Venetoclax

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2019Actual

Primary Completion Date

Nov 15, 2022Actual

Completion Date

Apr 27, 2023Actual

First Submitted Date

Oct 1, 2018

First Submission Date that Met QC Criteria

Nov 9, 2018

First Posted Date

Nov 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2024

Last Update Posted Date

Jan 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CYC065	Drug	intravenous infusion	CYC065 and venetoclax
Venetoclax

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Anti-tumor activity	Response assessed by investigators based on International Workshop for CLL criteria or International Working Group criteria for patients with small lymphocytic lymphoma.	From the date of first dose of CYC065 to 4 weeks after the last dose of CYC065

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Kirschbaum, MD	Cyclacel Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Baltimore	Maryland	21201	United States
Investigational Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D015448	Leukemia, B-Cell

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000621593	CYC065
C579720	venetoclax

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.