Status:
WITHDRAWN
Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia
Lead Sponsor:
Afexa Life Sciences Inc
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 det...
Eligibility Criteria
Inclusion
- 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):
- Hematologic parameters: Hemoglobin \> 9 gm/dL (stable, not dropping); Absolute Granulocyte Count (AGC) \> 1.0 x 109/L; Platelets \> 50 x 109/L; not requiring immediate transfusion.
- Coagulation: PT/PTT/INR: ± 10% of NL for lab; INR: 1.0-1.43
- BUN \< 40; serum Creatinine ≤ 2.0 mg/dL, OR Creatinine Clearance \> 90 mL/min/1.73m2 IF serum Creatinine \> 2.0 mg/dL
- Liver function tests (AST, ALT, ALP, LDH): \< 2.5 x institutional ULN; Total bilirubin: \< 2.0 x institutional ULN
- Human Immunodeficiency Virus (HIV) negative
- Pregnancy test: negative urine pregnancy test for females of child-bearing potential,
- 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
- 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:
- Splenectomy.
- Currently requiring anticoagulant therapy
- Requiring active treatment for B-CLL or ≤ 28 days post-treatment for B-CLL or other condition requiring: chemotherapy, radiation therapy, monoclonal antibodies, systemic steroids, antihistamines or non-steroidal anti-inflammatory drugs, including ibuprofen, indomethacin, COX-2 inhibitors etc.
- ≤ 10 days: non-steroidal hormonal therapy (other than for contraception or thyroid)
- ≤ 10 days: antibiotic prophylaxis
- History of therapy with immunological reagents, such as allogeneic bone marrow transplant, monoclonal antibody therapy, intravenous immunoglobulin, or hematopoietic stem cell transplantation. (Note: Immunotherapy for allergies is permitted as long as the last treatment was both (a) prior to the CLL diagnosis and (b) \> 5 years prior to trial enrollment.)
- \< 90 days post treatment with chlorambucil
- \< 90 days post general anesthesia
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01456182
Start Date
December 1 2011
End Date
May 1 2013
Last Update
January 25 2012
Active Locations (3)
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1
Saint Jospeh Mercy Health System
Ann Arbor, Michigan, United States, 48106
2
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
3
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29615