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

Alternate Title

Epratuzumab and Rituximab in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI, Pharmaceutical / Industry UCLA-0109058 AMGEN-20010138, NCT00054379

Objectives

1. Determine the response rate of patients with refractory or recurrent low-grade CD20-positive B-cell non-Hodgkin's lymphoma treated with epratuzumab and rituximab.
2. Determine the time to progression, duration of response, and survival of patients treated with this regimen.
3. Determine the safety profile of this regimen in these patients.
4. Determine the immunogenicity and pharmacokinetics of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed low-grade B-cell non-Hodgkin's lymphoma (NHL)
  • CD20-positive
  • Recurrent or refractory disease



• Failed at least 1 prior chemotherapy regimen for NHL



• Partial or complete response after prior rituximab with a time to progression of at least 12 months OR no prior rituximab



• No evidence of rapid disease progression or symptoms indicative of disease progression requiring rapid intervention within the past 2 weeks, including:
  • Severe shortness of breath
  • Severe pain
  • Gastrointestinal or genitourinary obstruction



• Bidimensionally measurable disease by CT scan
  • At least 1 lesion at least 1.5 cm



• No prior or concurrent known or suspected transformed lymphoma



• No pleural effusion with positive cytology for lymphoma



• No primary or secondary CNS lymphoma

 [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 former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• See Patient Characteristics-Hematopoietic
• No prior antibody therapy for lymphoma (except rituximab)

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• At least 2 weeks since prior steroids
• No concurrent steroids except low-dose (no more than 20 mg/day of prednisone or equivalent) for non-lymphoma-related conditions

Radiotherapy

• No prior radiotherapy to the measurable lesion(s) (unless clearly progressing and/or gallium scan positive)

Surgery

• More than 4 weeks since prior major surgery, unless fully recovered

Other

• At least 30 days since prior clinical trial participation
• At least 30 days since prior investigational therapy
• No other concurrent clinical trial enrollment
• No other concurrent investigational agents
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 4 months

Hematopoietic

• Absolute neutrophil count at least 1,000/mm³*
• Platelet count at least 50,000/mm³*

 [Note: *More than 4 weeks since prior transfusions or growth factor support]

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 virus negative

Renal

• Creatinine no greater than 2 times ULN

Pulmonary

• See Disease Characteristics

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study
• HIV negative
• No known human anti-chimeric antibody/human anti-human antibody positivity
• No other malignancy within the past 3 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer
• No serious nonmalignant condition or infection that would preclude study participation
• No known Type I hypersensitivity or anaphylactic reactions to murine proteins

Expected Enrollment

A total of 50 patients will be accrued for this study.

Outline

This is an open-label, multicenter study. Patients are stratified according to gender and age (under 65 vs 65 and over).

Patients receive epratuzumab IV over 1 hour followed 1-24 hours later by rituximab IV once weekly for 4 weeks (1 course).

Patients are followed at 4 weeks and then every 3 months for at least 1 year.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

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

Registry Information
Official Title		A Phase 2 Clinical Trial Testing AMG 412 In Combination With Rituximab In Subjects With Refractory Or Recurrent Low-Grade, CD20+ B-Cell Non-Hodgkin's Lymphoma
Trial Start Date		2002-01-09
Registered in ClinicalTrials.gov		NCT00054379
Date Submitted to PDQ		2002-12-31
Information Last Verified		2003-02-26
NCI Grant/Contract Number		P30-CA16042