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

January 24, 2024 updated by: Cyclacel Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYC065 and venetoclax
CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.
Drug: CYC065
intravenous infusion
Drug: Venetoclax
oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At the end of cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the date of first dose of CYC065 to 4 weeks after the last dose of CYC065

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyclacel Pharmaceuticals, Inc.

Collaborators

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Gautam Borthakur, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2019

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

April 5, 2023

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYC065-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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