Trial Search Results

Phase 2 Fludarabine, Cytoxan and FCCAM in Untreated B-Cell Chronic Lymphocytic Leukemia

The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Steven E. Coutre

Collaborator: Bayer


  • Drug: Alemtuzumab
  • Drug: Fludarabine
  • Drug: Cytoxan


Phase 2


Inclusion Criteria:

   - ≥ age 18

   - Karnofsky performance status 60% or above

   - Confirmed immunohistological diagnosis of Chronic Lymphocytic Leukemia (CLL)

   - Rai Stage I to IV as follows:

      - Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk)

      - OR

      - Patients with Rai Stage I - II or (Modified Rai Intermediate-Risk) disease must
      have an indication for therapy based on 1996 NCI revised criteria for active
      disease as follows:

         - Any one of the following disease-related symptoms:

            1. Weight loss ≥ 10% body weight within the previous 6 months

            2. Extreme fatigue

            3. Fever greater than 100.5° F for ≥ 2 weeks without evidence of infection

            4. Night sweats without evidence of infection

         - Evidence of progressive marrow failure based on the development of worsening
         of anemia or thrombocytopenia

         - Autoimmune anemia and/or thrombocytopenia poorly responsive to
         corticosteroid therapy

         - Massive (> 6 cm below the left costal margin) or progressive splenomegaly

         - Bulky (>10 cm in cluster) or progressive lymphadenopathy

         - Progressive lymphocytosis > 50% increase over 2 months, or anticipated
         doubling time < 6 months

   - Patients with immunoglobulin VH gene in unmutated nucleotide sequence configuration,
   as defined by ≥ 98% homology with the nearest germline counterpart

   - Serum creatinine ≤ 2x the upper limit of normal

   - Total serum bilirubin ≤ 2x the upper limit of normal.

   - AST ≤ 2x the upper limit of normal.

   - ALT ≤ 2x the upper limit of normal.

   - Signed written informed consent

Exclusion Criteria:

   - Prior pharmacological treatment for CLL

   - Past history of anaphylaxis following exposure to monoclonal antibodies

   - Active secondary malignancy or a history of malignant disease (other than CLL or
   non-melanoma skin cancer) within the preceding 5 years

   - Any medical condition requiring systemic corticosteroids

   - Active systemic infection

   - Major systemic or other illness (including Coombs positivity and active hemolysis)
   that would, in the opinion of the investigator, interfere with the patient's ability
   to comply with the protocol, compromise patient safety, or interfere with the
   interpretation of study results

   - HIV positive by serologic testing

   - Pregnant or nursing female

   - Unwilling/unable to practice an acceptable form of contraception.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nini Estevez
Not Recruiting