|
|
Phase II Study of Epratuzumab and Rituximab in Patients With Refractory or Recurrent Low-Grade CD20-Positive B-Cell Non-Hodgkin's Lymphoma
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 - 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.
- Determine the time to progression, duration of response, and survival of patients treated with this regimen.
- Determine the safety profile of this regimen in these patients.
- 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 Performance status Life expectancy 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 | | | |
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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
|