Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Study Overview
=================
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.

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)

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Biological: epratuzumab


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: epratuzumab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma