Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022685
First received: August 10, 2001
Last updated: December 18, 2013
Last verified: April 2003
  Purpose

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 Intervention Phase
Lymphoma
Biological: epratuzumab
Phase 3

Study Type: Interventional
Study Design: Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022685

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Peter J. Rosen, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022685     History of Changes
Other Study ID Numbers: CDR0000068842, UCLA-0009041, IM-T-hLL2-07, UCLA-BB-IND-7124, NCI-G01-2004
Study First Received: August 10, 2001
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 23, 2014