NCT00022685

Brief 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: 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2001

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 19, 2013

Status Verified

April 1, 2003

First QC Date

August 10, 2001

Last Update Submit

December 18, 2013

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphoma

Interventions

epratuzumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

epratuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Study Officials

  • Peter J. Rosen, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

September 1, 2001

Last Updated

December 19, 2013

Record last verified: 2003-04

Locations

US(1)