Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

December 18, 2013 updated by: Jonsson Comprehensive Cancer Center

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

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 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

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
  • Masking: None (Open Label)

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

  • Study Chair: Peter J. Rosen, 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

September 1, 2001

Study Registration Dates

First Submitted

August 10, 2001

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

April 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068842
  • UCLA-0009041
  • IM-T-hLL2-07
  • UCLA-BB-IND-7124
  • NCI-G01-2004

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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