Acute Myeloid Leukemia Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT04017546

Recruitment Status:

Completed

Sponsor:

Cyclacel Pharmaceuticals, Inc.

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There is 1 Location for this study

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MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT04017546

Recruitment Status:

Completed

Sponsor:


Cyclacel Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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