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Status:

COMPLETED

Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia

Lead Sponsor:

Bayer

Conditions:

Leukemia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituxi...

Detailed Description

OBJECTIVES: Primary * Compare the complete response rate in patients with refractory or relapsed B-cell chronic lymphocytic leukemia treated with fludarabine and alemtuzumab vs fludarabine and ritux...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL), defined as:
  • Peripheral lymphocyte count \> 5,000/mm\^3
  • Clonal CD5-, CD19-, and CD23-positive lymphocytes
  • Refractory to OR relapsed after prior first-line therapy
  • No CNS involvement with CLL
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Immunologic
  • No active cytomegalovirus
  • No prior fludarabine-associated autoimmune hemolytic anemia or immune thrombocytopenic purpura
  • No active infection requiring treatment with antibiotic, antiviral, or antifungal agents
  • No prior significant allergic reaction to antibody therapies that required therapy to be discontinued
  • HIV negative
  • Other
  • No active secondary malignancy
  • No other concurrent severe diseases or mental disorders
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 weeks since prior alemtuzumab and/or rituximab
  • No prior bone marrow transplantation
  • No concurrent thrombopoietin or pegfilgrastim
  • Chemotherapy
  • More than 3 weeks since prior fludarabine
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified
  • Other
  • More than 3 months since prior investigational drugs
  • No other concurrent cytotoxic therapy

Exclusion

    Key Trial Info

    Start Date :

    July 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    October 1 2009

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00086775

    Start Date

    July 1 2003

    End Date

    October 1 2009

    Last Update

    August 2 2013

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    2

    Jackson Oncology Associates, PLLC

    Jackson, Mississippi, United States, 39202

    3

    Cancer Institute of New Jersey at Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, United States, 08903

    4

    Western Pennsylvania Cancer Institute

    Pittsburgh, Pennsylvania, United States, 15224