Chronic Lymphocytic Leukemia Clinical Trial

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

Summary

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (leukemia-cll/" >CLL)

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Full 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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Eligibility 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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

5

Study ID:

NCT03739554

Recruitment Status:

Completed

Sponsor:

Cyclacel Pharmaceuticals, Inc.

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There are 3 Locations for this study

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Investigational Site
Baltimore Maryland, 21201, United States
Investigational Site
Charlotte North Carolina, 28204, United States
Investigational Site
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

5

Study ID:

NCT03739554

Recruitment Status:

Completed

Sponsor:


Cyclacel Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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