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Trial record 4 of 129 for:    Venetoclax AND Relapsed

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

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ClinicalTrials.gov Identifier: NCT03739554
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE January 25, 2019
Estimated Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
Number of patients who experience dose-limiting toxicity (DLT) [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03739554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Pharmacokinetic effect [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]
    Plasma drug level
  • Pharmacodynamic effect [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]
    MCL-1 level in peripheral white blood cells
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 9, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
Official Title  ICMJE A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Relapsed or Refractory Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: CYC065
    intravenous infusion
  • Drug: Venetoclax
    oral capsule
Study Arms  ICMJE 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.
Interventions:
  • Drug: CYC065
  • Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2020
Estimated Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Judy Chiao, MD 9085177330 jchiao@cyclacel.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03739554
Other Study ID Numbers  ICMJE CYC065-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cyclacel Pharmaceuticals, Inc.
Study Sponsor  ICMJE Cyclacel Pharmaceuticals, Inc.
Collaborators  ICMJE M.D. Anderson Cancer Center
Investigators  ICMJE
Principal Investigator: William Wierda, MD M.D. Anderson Cancer Center
PRS Account Cyclacel Pharmaceuticals, Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP