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Completed

NCT Number: NCT04017546

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS

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Key information

Conditions

AML Bone Marrow Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute MDS Myelodysplastic Syndromes 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

MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. 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

  • Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
  • ECOG 0-2
  • Adequate renal function
  • Adequate liver function
  • INR <=1.2 in patients not receiving chronic anticoagulation
  • At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
  • Agree to practice effective contraception

Exclusion criteria

  • AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment
  • Known AML 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

Primary outcomes

  1. Maximum tolerated dose (MTD)

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

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

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

    Number of patients achieving complete remission, partial remission, hematological improvement as evaluated using International Working Group (IWG) response criteria

Sponsors and collaborators

Lead sponsor

Cyclacel Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase I Combination Study of CYC065 and Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 12, 2019
Registry last updated
Sep 19, 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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