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

CYC065-02

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

2019-01-25

2022-11-15

2023-04-27

Completed

Early phase I

5

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Three to 6 patients will be entered at a given CYC065 dose level. Dose escalation will be 33% until one out of 3 patients experienced a DLT at a given dose level. Dose escalation will continue at 25% if no additional DLT is observed; otherwise, dose escalation will be stopped. At least 6 patients will be treated at RD.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2024-01-25