NCT00061425

CompletedPhase 1/2

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

Gilead Sciences Source

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Other study identifiers

Sponsor study identifier

IM-T-hLL2-06-EU

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2007

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2000
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 27, 2003
Actual (reported)
First Posted
May 28, 2003
Actual (reported)
Primary Completion
November 2007
Actual (reported)

Last Updated: August 19, 2021
Status Verified: January 2009
Last Update Submitted: August 12, 2021

Conditions

Lymphoma, B-Cell Non-Hodgkin's Lymphoma

Keywords

NHLrecurrent B-cell lymphoma

Interventions

radiolabeled epratuzumabDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.)

Sponsors & Collaborators

Gilead Sciences
Industrylead

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, B-Cell

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

William Wegener
Gilead Sciences
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 27, 2003

First Posted

May 28, 2003

Study Start

August 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2007

Actual (reported)

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Phase 1/2Terminated

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Phase 1/2Terminated

NCT00057447

Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients

Phase 1/2Terminated

NCT00426855

Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)

Phase 1/2Completed

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.

Contact the study team to confirm eligibility.

Last Updated

August 19, 2021

Record last verified: 2009-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00061425
Data provider: ClinicalTrials.gov
Source updated: 2021-08-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:57 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record