Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG

NCT ID: NCT00061425

Last Updated: 2021-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Brief Summary

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The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma Lymphoma, B-Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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radiolabeled epratuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.)
* Measureable via CT, with at least one lesion \> or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.)
* Radiological studies (ie - CT) must be performed within 4 weeks prior to study start.
* Acceptable tumor burden that will allow adequate follow-up and evaluation.
* Less that 25% bone marrow involvement, determined by bone marrow biopsy.
* Must observe the following washout periods:

At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.

At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.

* Must have Karnofsky score \>70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months.
* Serum creatinine \< or = 1.5mg/dl or creatinine clearance \> or = 50ml/min.
* Serum bilirubin \< or = 2mg/dl.
* Hemoglobin \> or = 10 g/dl; WBC \> or = 3000/mm3; granulocyte count \> or = 150/mm3; platelet count \> or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.
* Immunomedics ELISA assay of HahLL2 \< 100ng/ml for those with prior history of monoclonal antibody infusions.
* Cognizant informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Principal Investigators

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William Wegener

Role: STUDY_DIRECTOR

Gilead Sciences

Other Identifiers

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IM-T-hLL2-06-EU

Identifier Type: -

Identifier Source: org_study_id

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