Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: epratuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult diffuse large cell lymphoma