CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:January 25, 2019
End Date:May 15, 2020
Contact:Judy Chiao, MD
Email:jchiao@cyclacel.com
Phone:9085177330

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

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

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.

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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: William Wierda, MD
Phone: 713-563-0291
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mi
from
Houston, TX
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