NCT00054834

Brief Summary

The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2003

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2003

Completed
Last Updated

August 16, 2021

Status Verified

January 1, 2008

First QC Date

February 11, 2003

Last Update Submit

August 12, 2021

Conditions

Non-Hodgkins Lymphoma

Interventions

hLL2 (epratuzumab)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age Range: Male or Female at least 18 years of age
  • Performance Status: Patients with a Karnofsky performance status \> 60% (or equivalent, ECOG 0-2) and expected survival of at least 12 weeks.
  • Hematopoietic: Hemoglobin \> 10 g/dL; ANC \> 1.5x10\^9/L; Platelets \> 100x10\^9/L;
  • Hepatic: Serum bilirubin \< 2.0 mg/dL; AST and ALT \< 2 x ULN w/o liver metastases or \<5 x ULN w/liver metastases
  • Renal: Creatinine \< 2.0 mg/dL
  • Cardiovascular: Patients with LVEF \>/= 50% by MUGA or 2D-ECHO.
  • Pulmonary: Patients with DFCO and FEV1 \>/= 60% by required Pulmonary Function Tests.
  • Other: Patients agreeing to use a medically effective method of contraception while enrolled in the study. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

epratuzumab

Condition Hierarchy (Ancestors)

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

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

February 11, 2003

First Posted

February 13, 2003

Study Start

March 1, 2003

Last Updated

August 16, 2021

Record last verified: 2008-01

Locations

US(2)