NCT00061425

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.

Trial Health

100
On Track

Trial Health Score

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

Status
completed

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

August 1, 2000

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2003

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

August 19, 2021

Status Verified

January 1, 2009

Enrollment Period

7.3 years

First QC Date

May 27, 2003

Last Update Submit

August 12, 2021

Conditions

Non-Hodgkin's LymphomaLymphoma, B-Cell

Keywords

NHLrecurrent B-cell lymphoma

Interventions

radiolabeled epratuzumabDRUG

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.)
  • 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.

Sponsors & Collaborators

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
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 1, 2000

Primary Completion

November 1, 2007

Last Updated

August 19, 2021

Record last verified: 2009-01