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Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: August 5, 2002   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00042913
  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: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: epratuzumab
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Epratuzumab Yttrium Y 90 Epratuzumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

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

Study Start Date: May 2002
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042913

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069484, UCLA-0201056, AMGEN-AMG-412-159, NCI-G02-2094
Study First Received: August 5, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00042913     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Lymphatic Diseases
Signs and Symptoms
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
B-cell Lymphomas
Lymphoma, Large-cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Recurrence

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

ClinicalTrials.gov processed this record on May 06, 2009