Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01456182
Recruitment Status : Withdrawn
First Posted : October 20, 2011
Last Update Posted : January 25, 2012
Information provided by (Responsible Party):
Afexa Life Sciences Inc

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 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.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Drug: AFX-2 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia
Study Start Date : December 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : May 2013

Arm Intervention/treatment
Dose arm 1 Drug: AFX-2
Dose level 1
Dose arm 2 Drug: AFX-2
Dose level 2
Dose arm 3 Drug: AFX-2
Dose level 3
Dose arm 4 Drug: AFX-2
Dose level 4
Dose arm 5 Drug: AFX-2
Dose level 5

Primary Outcome Measures :
  1. Safety and tolerability will be assessed based on the incidence, duration and intensity of adverse events [ Time Frame: 0-8 weeks ]
    Adverse events will be graded according to NCI-CTC v4.

  2. 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 ]
    Study tests that will determine safety include vital signs, clinical laboratory tests (hematology, serum chemistries, coagulation, urinalysis) and 12-lead EKG

Secondary Outcome Measures :
  1. Quality of life indices [ Time Frame: 1 week, 4 weeks, 8 weeks ]
  2. Maximum tolerated dose and/or dose-limiting toxicity [ Time Frame: 1 week, 4 weeks, 8 weeks ]
  3. Biological and immune responses [ Time Frame: 1 week, 4 weeks, 8 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult men and women >18 years of age
  2. 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)
  3. Disease meets criteria for low-risk (Rai Stage 0), intermediate-risk (Rai Stage I- II), or high-risk (Rai Stage III-IV) disease
  4. Life expectancy of ≥ 3 months at Screening.
  5. ECOG performance status 0-3
  6. 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,
  7. 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.
  8. If not surgically sterile, or post-menopausal (> 12 months with no menstrual flow), willing to practice birth control (barrier + contraception) throughout duration of study.
  9. Able and willing to swallow capsules.
  10. Willing to limit alcohol intake during the study treatment period.
  11. Willing to sign the informed consent.

Exclusion Criteria:

  1. Lymphoproliferative disease other than CLL
  2. Prior use of the test article (AFX-2), or ginseng-containing products (American, Asian, etc.) ≤ 1 year prior to study entry.
  3. Known allergy to the test article or ginseng-containing products
  4. Active infection requiring systemic treatment
  5. 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
  6. Uncontrolled intercurrent condition, including, but not limited to, cardiovascular, pulmonary, renal, hepatic, GI, GU, neurologic, metabolic, psychiatric, etc.
  7. Current or prior investigational product or procedure < 56 days preceding study entry (Baseline -Visit 2; Study Day 0).
  8. Unwilling to discontinue use of nonprescription (OTC), nutritional or dietary supplements during the study period (as further defined by protocol).
  9. Pregnant, lactating.
  10. Any condition, personal or social situation that precludes or limits the ability of the participant to provide informed consent or comply with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01456182

United States, Michigan
Saint Jospeh Mercy Health System
Ann Arbor, Michigan, United States, 48106
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Afexa Life Sciences Inc
Principal Investigator: Leslie R Ellis, MD Wake Forest University Health Sciences Center

Responsible Party: Afexa Life Sciences Inc Identifier: NCT01456182     History of Changes
Other Study ID Numbers: AFX-2-2010-1
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell