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Phase III Study of Epratuzumab in Patients With Rituximab-Refractory Low-Grade Follicular 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 in Treating Patients With Non-Hodgkin's Lymphoma
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Treatment
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Closed
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18 and over
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NCI, Pharmaceutical / Industry
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UCLA-0009041 IM-T-hLL2-07, UCLA-BB-IND-7124, NCI-G01-2004, NCT00022685
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Objectives - Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.
- Confirm the convenient administration of this drug in this patient population.
- Determine the efficacy of this drug in terms of objective response rate in these patients.
- Determine the duration of response and time to progression in patients treated with this drug.
Entry Criteria Disease Characteristics:
- Histologically confirmed low-grade follicular B-cell non-Hodgkin's
lymphoma
- Small cleaved cell
OR - Mixed cell
- The following are ineligible:
- Primary CNS lymphoma
- HIV lymphoma
- Richter's lymphoma
- Bulky disease (any single mass greater than 10 cm)
- Pleural effusion with positive cytology for lymphoma
- Failed prior standard chemotherapy for non-Hodgkin's lymphoma
- Refractory to at least 1 prior treatment with rituximab
- Disease progression or failure to achieve objective
response within 6 months of beginning rituximab therapy
- At least 1 bidimensionally measurable lesion
- At least 1.5 cm by CT scan
[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 terminology of "low", "intermediate", or "high" grade lymphoma.
However,
this protocol uses the former terminology.] Prior/Concurrent Therapy:
Biologic therapy: - See Disease Characteristics
- At least 12 weeks since prior autologous stem cell
transplantation
- No prior radioimmunoconjugate therapies
Chemotherapy: - See Disease Characteristics
- No more than 4 prior treatment regimens
- At least 4 weeks since prior chemotherapy
Endocrine therapy: - At least 2 weeks since prior corticosteroids
- No concurrent steroids
Radiotherapy: - See Biologic therapy
- At least 4 weeks since prior radiotherapy to target
lesion
Surgery: - At least 4 weeks since prior major surgery unless
recovered
Other: - At least 4 weeks since prior experimental therapies
- No other concurrent investigational or therapeutic
agents
Patient Characteristics:
Age: Performance status: - Karnofsky 60-100%
- ECOG 0-2
Life expectancy: Hematopoietic: - Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 50,000/mm3
- Hemoglobin at least 8 g/dL
- Transfusion independent
Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal
(ULN)*
- Alkaline phosphatase less than 2 times ULN*
- AST less than 2 times ULN*
[Note: *Unless lymphoma-related] Renal: - Creatinine no greater than 1.5 times ULN unless
lymphoma-related
Other: - No other malignancy within the past 5 years except squamous or
basal cell skin cancer or carcinoma in situ of the cervix
- No other serious condition or infection that would preclude
study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and
for 3 months after study participation
Expected Enrollment Approximately 30-100 patients will be accrued for this study. Outline This is a multicenter study. Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and
22. Patients are followed every 8 weeks for 10 months and then every 3
months for up to 4 years.
Trial Contact Information
Trial Lead Organizations Jonsson Comprehensive Cancer Center at UCLA | | | Peter Rosen, MD, Protocol chair | | Ph: 310-825-5268; 888-798-0719 |
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Registry Information | | Official Title | | A Phase III Clinical Trial of Immunotherapy with Humanized LL2 IgG (epratuzumab) in Patients with Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (rituximab) | | Trial Start Date | | 2001-09-10 | | Registered in ClinicalTrials.gov | | NCT00022685 | | Date Submitted to PDQ | | 2001-07-03 | | Information Last Verified | | 2003-04-23 | | 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 |
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