Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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Purpose
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: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: epratuzumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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) |
| Study Start Date: | September 2001 |
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.
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.
PROJECTED ACCRUAL: Approximately 30-100 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
- ECOG 0-2
Life expectancy:
- At least 4 months
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- 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
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
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Peter J. Rosen, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00022685 History of Changes |
| Other Study ID Numbers: | CDR0000068842, UCLA-0009041, IM-T-hLL2-07, UCLA-BB-IND-7124, NCI-G01-2004 |
| Study First Received: | August 10, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013