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. Identifier: NCT00042913
Recruitment Status : Unknown
Verified September 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: 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
Lymphoma Biological: epratuzumab Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
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 2002

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 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)



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months


  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 50,000/mm3 (transfusion independent)
  • Hemoglobin at least 9.0 g/dL


  • 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


  • Creatinine no greater than 2 times ULN


  • 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


Biologic therapy

  • See Disease Characteristics
  • At least 4 weeks since prior immunotherapy (unless clearly progressing)
  • At least 12 weeks since prior ASCT


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

Endocrine therapy

  • Not specified


  • No prior radioimmunotherapy


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


  • 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

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 identifier (NCT number): NCT00042913

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)
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center Identifier: NCT00042913     History of Changes
Other Study ID Numbers: CDR0000069484
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: September 2003

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma

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