Clinical Trials /

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

NCT03739554

Description:

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

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
  • Official Title: A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Clinical Trial IDs

  • ORG STUDY ID: CYC065-02
  • NCT ID: NCT03739554

Conditions

  • Relapsed or Refractory Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
CYC065CYC065 and venetoclax
VenetoclaxABT-199CYC065 and venetoclax

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
CYC065 and venetoclaxExperimentalCYC065 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.
  • CYC065
  • Venetoclax

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cyclacel Pharmaceuticals, Inc.

Trial Keywords

  • CYC065
  • CDK2/9
  • venetoclax
  • BCL-2
  • MCL-1
  • Relapsed
  • Refractory
  • chronic lymphocytic leukemia
  • small lymphocytic lymphoma

Last Updated

October 16, 2019