Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0201056 AMGEN-AMG-412-159, NCI-G02-2094, NCT00042913

Objectives

1. Determine the response rate of patients with diffuse large B-cell non-Hodgkin's lymphoma treated with epratuzumab.
2. Determine the toxicity of this drug in these patients.

Entry 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)

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

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

Expected Enrollment

A total of 150 patients (50 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Christos Emmanouilides, MD, Principal investigator		Ph: 310-206-0716; 888-798-0719 Email: cemmanou@mednet.ucla.edu

Registry Information
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
Trial Start Date		2002-05-14
Registered in ClinicalTrials.gov		NCT00042913
Date Submitted to PDQ		2002-06-10
Information Last Verified		2003-09-08
NCI Grant/Contract Number		P30-CA82103