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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
NCT00022685
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: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.

Condition or Disease Intervention/Treatment Phase
  • Biological: epratuzumab
 Phase 3

Detailed Description

OBJECTIVES:

  • Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.

  • Confirm the convenient administration of this drug in this patient population.

  • Determine the efficacy of this drug in terms of objective response rate in these patients.

  • Determine the duration of response and time to progression in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22.

Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years.

PROJECTED ACCRUAL: Approximately 30-100 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (Rituximab)
Study Start Date :
Sep 1, 2001

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 low-grade follicular B-cell non-Hodgkin's lymphoma

    • Small cleaved cell OR

    • Mixed cell

    • The following are ineligible:

    • Primary CNS lymphoma

    • HIV lymphoma

    • Richter's lymphoma

    • Bulky disease (any single mass greater than 10 cm)

    • Pleural effusion with positive cytology for lymphoma

    • Failed prior standard chemotherapy for non-Hodgkin's lymphoma

    • Refractory to at least 1 prior treatment with rituximab

    • Disease progression or failure to achieve objective response within 6 months of beginning rituximab therapy

    • At least 1 bidimensionally measurable lesion

    • At least 1.5 cm by CT scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:

    • Karnofsky 60-100%

    • ECOG 0-2

    Life expectancy:
    • At least 4 months
    Hematopoietic:

    • Absolute granulocyte count at least 1,500/mm^3

    • Platelet count at least 50,000/mm^3

    • Hemoglobin at least 8 g/dL

    • Transfusion independent

    Hepatic:

    • Bilirubin no greater than 1.5 times upper limit of normal (ULN)*

    • Alkaline phosphatase less than 2 times ULN*

    • AST less than 2 times ULN* NOTE: *Unless lymphoma-related

    Renal:
    • Creatinine no greater than 1.5 times ULN unless lymphoma-related
    Other:

    • No other malignancy within the past 5 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix

    • No other serious condition or infection that would preclude study participation

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for 3 months after study participation

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • See Disease Characteristics

    • At least 12 weeks since prior autologous stem cell transplantation

    • No prior radioimmunoconjugate therapies

    Chemotherapy:

    • See Disease Characteristics

    • No more than 4 prior treatment regimens

    • At least 4 weeks since prior chemotherapy

    Endocrine therapy:

    • At least 2 weeks since prior corticosteroids

    • No concurrent steroids

    Radiotherapy:

    • See Biologic therapy

    • At least 4 weeks since prior radiotherapy to target lesion

    Surgery:
    • At least 4 weeks since prior major surgery unless recovered
    Other:

    • At least 4 weeks since prior experimental therapies

    • No other concurrent investigational or therapeutic agents

    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

    • Study Chair: Peter J. Rosen, MD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00022685
    Other Study ID Numbers:
    • CDR0000068842
    • UCLA-0009041
    • IM-T-hLL2-07
    • UCLA-BB-IND-7124
    • NCI-G01-2004
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Dec 19, 2013
    Last Verified:
    Apr 1, 2003
    Keywords provided by , ,
    recurrent grade 1 follicular lymphoma
    recurrent grade 2 follicular lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Epratuzumab

    Study Results

    No Results Posted as of Dec 19, 2013