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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 : October 18, 2019
Sponsor:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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 15, 2020
Estimated Study Completion Date : May 15, 2020


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.



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

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


Contacts
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Contact: Judy Chiao, MD 9085177330 jchiao@cyclacel.com

Locations
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United States, Maryland
Investigational Site Recruiting
Baltimore, Maryland, United States, 21201
United States, North Carolina
Investigational Site Recruiting
Charlotte, North Carolina, United States, 28204
United States, Texas
Investigational Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
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Study Director: Judy Chiao, MD Cyclacel Pharmaceuticals, Inc.

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Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03739554     History of Changes
Other Study ID Numbers: CYC065-02
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cyclacel Pharmaceuticals, Inc.:
CYC065
CDK2/9
venetoclax
BCL-2
MCL-1
Relapsed
Refractory
chronic lymphocytic leukemia
small lymphocytic lymphoma
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Venetoclax
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Adenosine
Antineoplastic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action