Description:
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic
Lymphocytic Leukemia (CLL)
Title
- Brief Title: CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL
- Official Title: A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Clinical Trial IDs
- ORG STUDY ID:
CYC065-02
- NCT ID:
NCT03739554
Conditions
- Relapsed or Refractory Chronic Lymphocytic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
CYC065 | | CYC065 and venetoclax |
Venetoclax | ABT-199 | CYC065 and venetoclax |
Purpose
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory Chronic
Lymphocytic Leukemia (CLL)
Detailed 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.
Trial Arms
Name | Type | Description | Interventions |
---|
CYC065 and venetoclax | Experimental | CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15 after the venetoclax ramp-up schedule is completed. Venetoclax will be taken daily at a dose that is deemed safe and tolerable after the ramp-up schedule. One cycle will be 28 days or 4 weeks. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of patients who experience dose-limiting toxicity (DLT) |
Time Frame: | At the end of cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Pharmacokinetic effect |
Time Frame: | At the end of cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | Plasma drug level |
Measure: | Pharmacodynamic effect |
Time Frame: | At the end of cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | MCL-1 level in peripheral white blood cells |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Cyclacel Pharmaceuticals, Inc. |
Trial Keywords
- CYC065
- CDK2/9
- venetoclax
- BCL-2
- MCL-1
- Relapsed
- Refractory
- chronic lymphocytic leukemia
- small lymphocytic lymphoma
Last Updated
October 18, 2019