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Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00022685
Recruitment Status : Unknown
Verified April 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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
Lymphoma Biological: epratuzumab Phase 3

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
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 : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.



  • 18 and over

Performance status:

  • Karnofsky 60-100%
  • ECOG 0-2

Life expectancy:

  • At least 4 months


  • 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


  • 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


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


  • 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


Biologic therapy:

  • See Disease Characteristics
  • At least 12 weeks since prior autologous stem cell transplantation
  • No prior radioimmunoconjugate therapies


  • 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


  • See Biologic therapy
  • At least 4 weeks since prior radiotherapy to target lesion


  • At least 4 weeks since prior major surgery unless recovered


  • At least 4 weeks since prior experimental therapies
  • No other concurrent investigational or therapeutic agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022685

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Peter J. Rosen, MD Jonsson Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00022685     History of Changes
Other Study ID Numbers: CDR0000068842
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: April 2003

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases