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This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The trial will also determine the impact of dose on quality of life indices and on biological and immune responses, and will assess if there is a maximum tolerated dose and/or dose-limiting toxicity in this study population.
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Volunteers
Inclusion criteria
Adult men and women >18 years of age
Diagnosis of CLL per NCI Working Group Criteria; with phenotypic evidence (i.e.. flow cytometry or bone marrow biopsy) of chronic lymphocytic leukemia (MEDDRA Code - 10008960; ICD-O3-9823)
Disease meets criteria for low-risk (Rai Stage 0), intermediate-risk (Rai Stage I- II), or high-risk (Rai Stage III-IV) disease
Life expectancy of ≥ 3 months at Screening.
ECOG performance status 0-3
Laboratory parameters (taken < 14 days of Study Day 0):
Free of disease from prior malignancy/ies for > 2 years, except for basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
If not surgically sterile, or post-menopausal (> 12 months with no menstrual flow), willing to practice birth control (barrier + contraception) throughout duration of study.
Able and willing to swallow capsules.
Willing to limit alcohol intake during the study treatment period.
Willing to sign the informed consent.
Exclusion criteria
Lymphoproliferative disease other than CLL
Prior use of the test article (AFX-2), or ginseng-containing products (American, Asian, etc.) ≤ 1 year prior to study entry.
Known allergy to the test article or ginseng-containing products
Active infection requiring systemic treatment
Prior or current therapy:
Uncontrolled intercurrent condition, including, but not limited to, cardiovascular, pulmonary, renal, hepatic, GI, GU, neurologic, metabolic, psychiatric, etc.
Current or prior investigational product or procedure < 56 days preceding study entry (Baseline -Visit 2; Study Day 0).
Unwilling to discontinue use of nonprescription (OTC), nutritional or dietary supplements during the study period (as further defined by protocol).
Pregnant, lactating.
Any condition, personal or social situation that precludes or limits the ability of the participant to provide informed consent or comply with study requirements.
0 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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