We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03739554
Previous Study | Return to List | Next Study

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03739554
Recruitment Status : Active, not recruiting
First Posted : November 14, 2018
Last Update Posted : April 25, 2022
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Chronic Lymphocytic Leukemia Drug: CYC065 Drug: Venetoclax Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : January 25, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023

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.
Drug: CYC065
intravenous infusion

Drug: Venetoclax
oral capsule
Other Name: ABT-199

Primary Outcome Measures :
  1. Number of patients who experience dose-limiting toxicity (DLT) [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]

Secondary Outcome Measures :
  1. Pharmacokinetic effect [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]
    Plasma drug level

  2. Pharmacodynamic effect [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]
    MCL-1 level in peripheral white blood cells

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739554

Layout table for location information
United States, Maryland
Investigational Site
Baltimore, Maryland, United States, 21201
United States, North Carolina
Investigational Site
Charlotte, North Carolina, United States, 28204
United States, Texas
Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Layout table for investigator information
Study Director: Mark Kirschbaum, MD Cyclacel Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03739554    
Other Study ID Numbers: CYC065-02
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cyclacel Pharmaceuticals, Inc.:
chronic lymphocytic leukemia
small lymphocytic lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents