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Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epratuzumab
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult diffuse large cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 5, 2002
Last Updated
December 18, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00042913
Brief Title
Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Unknown status
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult diffuse large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
epratuzumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos E. Emmanouilides, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

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