Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Afexa Life Sciences Inc
First received: October 18, 2011
Last updated: January 23, 2012
Last verified: January 2012
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.
Leukemia, Lymphocytic, Chronic, B-Cell
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
||Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia
Primary Outcome Measures:
- Safety and tolerability will be assessed based on the incidence, duration and intensity of adverse events [ Time Frame: 0-8 weeks ] [ Designated as safety issue: Yes ]
Adverse events will be graded according to NCI-CTC v4.
- Safety and tolerability will also be determined by assessing any changes in study test results from baseline values [ Time Frame: 1 week, 4 weeks, 8 weeks ] [ Designated as safety issue: Yes ]
Study tests that will determine safety include vital signs, clinical laboratory tests (hematology, serum chemistries, coagulation, urinalysis) and 12-lead EKG
Secondary Outcome Measures:
- Quality of life indices [ Time Frame: 1 week, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Maximum tolerated dose and/or dose-limiting toxicity [ Time Frame: 1 week, 4 weeks, 8 weeks ] [ Designated as safety issue: Yes ]
- Biological and immune responses [ Time Frame: 1 week, 4 weeks, 8 weeks ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
Dose arm 1
Dose level 1
Dose arm 2
Dose level 2
Dose arm 3
Dose level 3
Dose arm 4
Dose level 4
Dose arm 5
Dose level 5
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456182
|Saint Jospeh Mercy Health System
|Ann Arbor, Michigan, United States, 48106 |
|Comprehensive Cancer Center of Wake Forest University
|Winston-Salem, North Carolina, United States, 27157 |
|Cancer Center of the Carolinas
|Greenville, South Carolina, United States, 29615 |
Afexa Life Sciences Inc
||Leslie R Ellis, MD
||Wake Forest University Health Sciences Center
No publications provided
||Afexa Life Sciences Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 18, 2011
||January 23, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases