Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

December 18, 2013 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Registration Dates

First Submitted

August 5, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069484
  • UCLA-0201056
  • AMGEN-AMG-412-159
  • NCI-G02-2094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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