American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
Condition: Leukemia
MeSH terms: Respiratory Tract Infections; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: American ginseng; Placebo
Intervention description: Given orally; Given orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia

Summary:

      RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in
      patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng
      extract is more effective than a placebo in preventing respiratory infections.

      PURPOSE: This randomized trial is studying the side effects of American ginseng extract and
      to see how well it works compared with a placebo in preventing respiratory infection and in
      reducing antibiotic use in patients with chronic lymphocytic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of chronic lymphocytic leukemia (CLL)

               -  Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease

          -  Untreated CLL allowed

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

          -  Life expectancy > 12 months

          -  Creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min

          -  AST/ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception prior to and during study treatment

          -  No known cirrhosis, collagen vascular disease, multiple sclerosis, or HIV positivity

          -  No other prior or concurrent malignancies except for non-melanoma skin cancers or
             carcinoma in situ of the cervix

               -  Other prior malignancies allowed provided the patient has been disease-free for >
                  5 years

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

          -  No psychiatric or social illness that would limit compliance with study requirements

          -  No history of allergy or other adverse response to ginseng products

          -  No history of seasonal or environmental allergies that require ongoing treatment with
             antihistamines, intranasal corticosteroids, or systemic corticosteroids

        PRIOR CONCURRENT THERAPY:

          -  More than 3 months since prior and no concurrent chlorambucil

          -  At least 1 month since prior and no other concurrent herbal ginseng products

          -  No prior or concurrent fludarabine, alemtuzumab, rituximab, intravenous
             immunoglobulin, or hematopoietic stem cell transplantation

          -  No concurrent corticosteroids (20 mg/day of prednisone or equivalent)

          -  No concurrent antibiotic prophylaxis, except for trimethoprim-sulfamethoxazole

          -  No concurrent warfarin

          -  No other concurrent investigational or commercial agents or other therapies with the
             intent to treat the patient's malignancy