NCT00042913

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: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.

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

Study Start

First participant enrolled

May 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 19, 2013

Status Verified

September 1, 2003

First QC Date

August 5, 2002

Last Update Submit

December 18, 2013

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma

Interventions

epratuzumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL) * Relapsed or refractory after at least 1 regimen of standard therapy * Prior therapy may include high-dose chemotherapy with autologous stem cell transplantation (ASCT) or immunotherapy * Bidimensionally measurable disease * At least 1 lesion at least 1.5 cm by CT scan * No primary or secondary CNS lymphoma * No HIV-related lymphoma * No known or suspected transformed lymphoma (prior or concurrent) * No bulky disease (i.e., any single mass greater than 10.0 cm) * No pleural effusion with positive cytology for lymphoma * Most recent pathology specimen available for collection * No rapid disease progression or symptoms that indicate disease progression requiring rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe pain, or gastrointestinal or genitourinary obstruction) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 4 months Hematopoietic * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 50,000/mm3 (transfusion independent) * Hemoglobin at least 9.0 g/dL 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 negative Renal * Creatinine no greater than 2 times ULN Other * HIV negative * No other primary malignancy within the past 3 years except squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer * No other serious nonmalignant condition that would preclude study * No serious infection * No known human antichimeric antibodies or human antihuman antibody positivity * No type 1 hypersensitivity or anaphylactic reactions to murine proteins * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 4 weeks since prior immunotherapy (unless clearly progressing) * At least 12 weeks since prior ASCT Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (unless clearly progressing) Endocrine therapy * Not specified Radiotherapy * No prior radioimmunotherapy Surgery * At least 4 weeks since prior major surgery (unless patient has fully recovered) Other * At least 30 days since prior enrollment in clinical trials involving investigational devices or drugs * No concurrent enrollment in other clinical trials involving investigational devices or drugs * No concurrent investigational agents for disease other than NHL

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, Large B-Cell, Diffuse

Interventions

epratuzumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christos E. Emmanouilides, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2002

First Posted

January 27, 2003

Study Start

May 1, 2002

Last Updated

December 19, 2013

Record last verified: 2003-09

Locations

US(1)