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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Steven E. Coutre, Stanford University
ClinicalTrials.gov Identifier:
NCT00230282
First received: September 28, 2005
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Leukemia, B-Cell, Chronic
Leukemia
Chronic Lymphocytic Leukemia (CLL)
Drug: Campath
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Phase II Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: July 2004
Study Completion Date: October 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Campath
    30 mg, IV
    Other Names:
    • Alemtuzumab
    • BI Phama
    • SC
    • Chemothera
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230282

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Steven E. Coutre
Bayer
Investigators
Principal Investigator: Steven Edward Coutre Stanford University
  More Information

No publications provided

Responsible Party: Steven E. Coutre, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00230282     History of Changes
Other Study ID Numbers: HEMCLL0001, 31185, 80071, HEMCLL0001
Study First Received: September 28, 2005
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014