Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma

August 12, 2021 updated by: Gilead Sciences

A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Fox Chase Cancer Center
    • Texas
      • Houston, Texas, United States
        • Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Disease Characteristics:

  • Patients with a documented histologic or cytologic diagnosis of B-cell NHL.
  • Patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority.
  • Patients with at least one measurable tumor site > 1.5 cm in at least one dimension.

Prior/Concurrent Therapy:

  • Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
  • Biologic Therapy: Patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hLL2 IgG (i.e., HAHA).
  • Radiotherapy: No prior radiation therapy to >25% of the bone marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cGy for the lungs and kidneys). Patients who have had whole pelvic irradiation are not eligible.

Patient Characteristics/Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Registration Dates

First Submitted

February 11, 2003

First Submitted That Met QC Criteria

February 12, 2003

First Posted (Estimate)

February 13, 2003

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-T-hLL2-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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