search
Back to results

Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 3
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 grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma

Eligibility Criteria

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

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
December 18, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00022685
Brief Title
Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Rosen, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
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

Learn more about this trial

Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

We'll reach out to this number within 24 hrs