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

This study has been completed.
Information provided by (Responsible Party):
Steven E. Coutre, Stanford University Identifier:
First received: September 28, 2005
Last updated: June 29, 2012
Last verified: June 2012

September 28, 2005
June 29, 2012
July 2004
December 2010   (final data collection date for primary outcome measure)
To evaluate the efficacy of FCCam in patients with previously untreated B-cell Chronic Lymphocytic Leukemia(CLL), as measured by rates and duration of clinical and laboratory responses, and the incremental effect of Campath® on the response rate [ Time Frame: unknown ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00230282 on Archive Site
  • To evaluate the influence of immunoglobulin variable heavy chain (VH) gene mutation status, CD38 expression, cytogenetic abnormalities, and Zap70 expression on efficacy endpoints [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • To further evaluate the efficacy of FCCam with serial minimal residual disease (MRD) assessments by flow cytometry [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • * To characterize the safety and pharmacokinetic (PK) profile of subcutaneous Campath® in combination with fludarabine and cyclophosphamide [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
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Phase II Fludarabine, Cytoxan and FCCAM in Untreated B-Cell Chronic Lymphocytic Leukemia
A Multi-Center Phase II Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia

The purpose of the study is to evaluate the safety and efficacy of fludarabine and cyclophosphamide followed by subcutaneous Campath® in previously untreated CLL patients. Another goal is to prospectively evaluate the influence of pre-treatment CD38 expression, immunoglobulin VH gene mutation status, Zap70 expression, and cytogenetic abnormalities on outcome. In addition, the study hopes to further evaluate treatment efficacy with quantitative assessments of minimal residual disease by flow cytometry for the CLL-specific CD19+/CD5+/CD20+/CD79b+ population.

Not Provided
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia, B-Cell, Chronic
  • Leukemia
  • Chronic Lymphocytic Leukemia (CLL)
Drug: Campath
30 mg, IV
Other Names:
  • Alemtuzumab
  • BI Phama
  • SC
  • Chemothera
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Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, age 18 or older, with a confirmed immunohistological diagnosis of CLL
  • Signed written informed consent
  • Karnofsky performance status 60% or above (Appendix E)
  • Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk).
  • 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% 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, regardless of Rai Stage.
  • Serum creatinine <= 2x the upper limit of normal. Total serum bilirubin, AST, and ALT: <= 2x the upper limit of normal.

Exclusion Criteria:

  • Prior pharmacological treatment for CLL.
  • Any medical condition requiring systemic corticosteroids.
  • Active systemic infection.
  • HIV positive by serologic testing.
  • 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.
  • Pregnant or nursing women, or unwilling/unable to practice an acceptable form of contraception. Treatment with the study agents would expose an unborn child to significant risks.
  • 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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
HEMCLL0001, 31185, 80071, HEMCLL0001
Steven E. Coutre, Stanford University
Steven E. Coutre
Principal Investigator: Steven Edward Coutre Stanford University
Stanford University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP