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 |
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)
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.
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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