Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

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: Lymphoma
• Intervention / Treatment: Biological: epratuzumab

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Peter J. Rosen, MD, Jonsson Comprehensive Cancer Center

Study record dates

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: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Antineoplastic Agents; Antineoplastic Agents, Immunological; Epratuzumab
• Other Study ID Numbers: CDR0000068842; UCLA-0009041; IM-T-hLL2-07; UCLA-BB-IND-7124; NCI-G01-2004