Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00042913
• Other study ID #: CDR0000069484
• Secondary ID: UCLA-0201056AMGE
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 5, 2002
• Last updated: December 18, 2013
• Start date: May 2002

Study information

• Verified date: September 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• epratuzumab

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,