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

Phase 1
18 Years
Not Enrolling
Leukemia, Lymphocytic, Chronic, B-Cell

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Trial Information

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

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

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

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

- ≤ 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety and tolerability will be assessed based on the incidence, duration and intensity of adverse events

Outcome Description:

Adverse events will be graded according to NCI-CTC v4.

Outcome Time Frame:

0-8 weeks

Safety Issue:


Principal Investigator

Leslie R Ellis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University Health Sciences Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

May 2013

Related Keywords:

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center of the CarolinasGreenville, South Carolina  29615
Saint Jospeh Mercy Health SystemAnn Arbor, Michigan  48106