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Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00042913
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: epratuzumab
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine the response rate of patients with diffuse large B-cell non-Hodgkin's lymphoma treated with epratuzumab.

  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks.

  • Arm II: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks.

  • Arm III: Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this study.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Study Start Date :
May 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL)

    • Relapsed or refractory after at least 1 regimen of standard therapy

    • Prior therapy may include high-dose chemotherapy with autologous stem cell transplantation (ASCT) or immunotherapy

    • Bidimensionally measurable disease

    • At least 1 lesion at least 1.5 cm by CT scan

    • No primary or secondary CNS lymphoma

    • No HIV-related lymphoma

    • No known or suspected transformed lymphoma (prior or concurrent)

    • No bulky disease (i.e., any single mass greater than 10.0 cm)

    • No pleural effusion with positive cytology for lymphoma

    • Most recent pathology specimen available for collection

    • No rapid disease progression or symptoms that indicate disease progression requiring rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe pain, or gastrointestinal or genitourinary obstruction)

    PATIENT CHARACTERISTICS:

    Age

    • 18 and over

    Performance status

    • ECOG 0-2

    Life expectancy

    • At least 4 months

    Hematopoietic

    • Absolute neutrophil count at least 1,000/mm3

    • Platelet count at least 50,000/mm3 (transfusion independent)

    • Hemoglobin at least 9.0 g/dL

    Hepatic

    • Bilirubin no greater than 2 times upper limit of normal (ULN)

    • AST and ALT less than 5 times ULN

    • Hepatitis B surface antigen negative

    • Hepatitis C negative

    Renal

    • Creatinine no greater than 2 times ULN

    Other

    • HIV negative

    • No other primary malignancy within the past 3 years except squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer

    • No other serious nonmalignant condition that would preclude study

    • No serious infection

    • No known human antichimeric antibodies or human antihuman antibody positivity

    • No type 1 hypersensitivity or anaphylactic reactions to murine proteins

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for at least 6 months after study

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • See Disease Characteristics

    • At least 4 weeks since prior immunotherapy (unless clearly progressing)

    • At least 12 weeks since prior ASCT

    Chemotherapy

    • See Disease Characteristics

    • At least 4 weeks since prior chemotherapy (unless clearly progressing)

    Endocrine therapy

    • Not specified

    Radiotherapy

    • No prior radioimmunotherapy

    Surgery

    • At least 4 weeks since prior major surgery (unless patient has fully recovered)

    Other

    • At least 30 days since prior enrollment in clinical trials involving investigational devices or drugs

    • No concurrent enrollment in other clinical trials involving investigational devices or drugs

    • No concurrent investigational agents for disease other than NHL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Christos E. Emmanouilides, MD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00042913
    Other Study ID Numbers:
    • CDR0000069484
    • UCLA-0201056
    • AMGEN-AMG-412-159
    • NCI-G02-2094
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Dec 19, 2013
    Last Verified:
    Sep 1, 2003
    Keywords provided by , ,
    recurrent adult diffuse large cell lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Epratuzumab

    Study Results

    No Results Posted as of Dec 19, 2013