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

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: Non-Hodgkins Lymphoma
• Intervention / Treatment: Drug: hLL2 (epratuzumab)

• Study Type: Interventional
• Enrollment: 27
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

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

• Sponsor: Gilead Sciences

Study record dates

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: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Antineoplastic Agents; Antineoplastic Agents, Immunological; Epratuzumab
• Other Study ID Numbers: IM-T-hLL2-14