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Completed

NCT Number: NCT03739554

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

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

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Key information

Conditions

Relapsed or Refractory Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CYC065

Drug

intravenous infusion

Venetoclax

Drug

oral capsule

Other names: ABT-199

Primary outcomes

  1. Number of patients who experience dose-limiting toxicity (DLT)

    Time frame: At the end of cycle 1 (each cycle is 28 days)

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cyclacel Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 14, 2018
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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