NCT00014664

Brief Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

55
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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

October 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

June 10, 2003

Completed
Last Updated

December 18, 2013

Status Verified

September 1, 2002

First QC Date

April 10, 2001

Last Update Submit

December 17, 2013

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Interventions

apolizumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed relapsed or refractory grade I, II, or III non-Hodgkin's lymphoma (NHL), including follicular, small lymphocytic, or marginal zone/MALT lymphoma * Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL * Progression of disease or no response since last treatment for NHL * 1D10+ lymphoma by immunohistochemistry or flow cytometry * Bidimensionally measurable disease at least 2 cm in a single dimension * No CNS metastases * Circulating tumor cells no greater than 5,000/mm\^3 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 75,000/mm\^3 (unless disease related) * Neutrophil count at least 1,000/mm\^3 (unless disease related) * Hemoglobin greater than 8.0 g/dL Hepatic: * Bilirubin less than 2.5 mg/dL * SGOT less than 4 times upper limit of normal Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No clinically significant cardiac disease (New York Heart Association class III or IV) * No evidence of myocardial infarction or cardiac arrhythmia (unless surgically repaired) within the past 6 months Pulmonary: * No clinically significant pulmonary disease Other: * No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ * No significant psychiatric or CNS impairment * No active serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study * Negative anti-Hu1D10 antibody response (HAHA/HAMA) * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 4 weeks since prior interferon therapy * At least 3 months since prior immunotherapy * No prior monoclonal antibody Hu1D10 Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy: * At least 4 weeks since prior corticosteroids (more than 10 mg prednisone/day) * No concurrent corticosteroids at more than 10 mg prednisone/day for pre-existing diseases or adverse reactions Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior external beam radiotherapy * At least 3 months since prior radioimmunotherapy Surgery: * Not specified Other: * No other concurrent lymphoma therapy

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

Sponsors & Collaborators

Study Sites (1)

Protein Design Labs, Inc.

Freemont, California, 94555, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

apolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tillman Pearce, MD

    Facet Biotech

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 10, 2001

First Posted

June 10, 2003

Study Start

October 1, 2000

Last Updated

December 18, 2013

Record last verified: 2002-09

Locations

US(1)