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Status:

WITHDRAWN

Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

Lead Sponsor:

Jonsson Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase II tri...

Detailed Description

OBJECTIVES: * Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab. * Determine the time to treatment failure in patients treated with this drug....

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)
  • Immunoglobulin (Ig) M, IgG, and IgA paraprotein
  • Measurable monoclonal paraprotein
  • Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
  • CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry
  • PATIENT CHARACTERISTICS:
  • Age
  • Over 18
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 6 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 500/mm\^3
  • Platelet count ≥ 25,000/mm\^3
  • Hepatic
  • SGOT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 2.5 mg/dL (\> 2.5 mg/dL allowed if due to disease)
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for 6 months after study participation
  • No serious comorbid disease
  • No uncontrolled bacterial, fungal, or viral infection
  • No other active malignancy
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • No prior alemtuzumab
  • More than 3 months since other prior monoclonal antibody therapy
  • Chemotherapy
  • See Disease Characteristics
  • More than 21 days since prior chemotherapy
  • Endocrine therapy
  • More than 21 days since prior steroid therapy
  • Radiotherapy
  • More than 21 days since prior radiotherapy
  • Surgery
  • Not specified

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00081068

    Start Date

    January 1 2004

    Last Update

    January 8 2013

    Active Locations (15)

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

    Page 1 of 4 (15 locations)

    1

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    2

    Rocky Mountain Cancer Centers - Denver Midtown

    Denver, Colorado, United States, 80218

    3

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013

    4

    Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, United States, 21201