Safety Study of NHL With 90Y-hLL2 IgG

August 12, 2021 updated by: Gilead Sciences

Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized IMMU-LL2: Treatment With 90Y-hLL2 IgG

This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for the treatment of patients B-cell lymphoma (NHL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

90Y-labeled hLL2 will be administered according to a schedule based upon whether or not a patient had prior high-dose chemotherapy with a marrow or stem cell transplant. Patients with both indolent and aggressive types of NHL will be enrolled at each dose level without segregation. However, at the conclusion of the trial, with the maximum tolerated dose (MTD) defined, a minimum number of 6 patients with indolent NHL, 6 patients with aggressive NHL, and 6 patients with >25% bone marrow involvement will be studied at that dose level.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • 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

  • France
      • Lille, France, 59037
        • Service des Maladies du Sang
    • Cedex
      • Nantes, Cedex, France, 44035
        • Research Unit 463 INSERM
  • Germany
      • Dresden, Germany, 01307
        • University Hospital Dresden
      • Gottingen, Germany, 37075
        • Klinikum der Georg-August-Universitat Gottingen
      • Homburg/Saar, Germany, D-66421
        • Universitatsklinikum University of Saarland

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

Inclusion Criteria:

  • All patients must have a histologic or cytological diagnosis of B-cell lymphoma, and have failed at least one regimen of standard chemotherapy. All histologic grades of non-Hodgkin's lymphoma (NHL) will be eligible for these studies.
  • Patients must be > 18 years of age
  • Measurable disease by CT, with at least one lesion > 1.5 cm in one or both dimensions
  • less than 25% bone marrow involvement as determined by bone marrow biopsy
  • Patient must have greater than 15% cellularity of the bone marrow.
  • Patients must be at least 4 weeks beyond any major surgery.
  • Patients must be at least 4 weeks beyond any radiation therapy to the index lesion and must have recovered from radiation induced toxicity.
  • Patients must be at least 4 weeks beyond prior chemotherapy and/or immunotherapy, or 2-weeks after corticosteroids, and their blood counts must be within the eligibility criteria. Corticosteroids may, however, be given concomitantly if used to treat adrenal insufficiency
  • Patients must have a performance status of 70 or greater on the Karnofsky scale equivalent to ECOG 0-1 (See Appendix A) and a minimal life expectancy of 6 months.
  • Patients must be able to give cognizant informed consent.

Exclusion Criteria:

  • Patients with a significant concurrent medical complication including severe anorexia, nausea or vomiting that in the judgement of the Investigator could affect the patient's ability to tolerate or complete this study.
  • Patients with metastasis to the brain.
  • Patients with extensive irradiation to more than 25% of their red marrow will be excluded, except those who had total body irradiation in the context of bone marrow or stem cell transplantation regimen with subsequent engraftment of a functional marrow (i.e., resulting in normal peripheral blood counts). Subjects who have received external radiation to specific organs or areas at the maximum tolerated level are also excluded.
  • Women who test positive for pregnancy.
  • Patients with splenomegaly.
  • Patients with > 4 treatment regimens prior to this protocol, including chemotherapy, radiotherapy and/or other immunotherapy.
  • Patients with prior radioimmunotherapy treatments (unless for retreatment under this protocol).
  • Patients receiving rituximab within 3 months, unless progressing after treatment.
  • Patients with <50% LVEF by required MUGA or 2-D ECHO.
  • Patients with <60% of predicted value by required pulmonary function tests.
  • Patients who have active Hepatitis B or C or are known HIV positive.
  • Patients with another primary malignancy (except basal/squamous cell carcinoma of the skin or carcinoma in-situ of the cervix.
  • Patients with other serious medical, surgical, or psychiatric history, unless currently stable and well controlled, without significant increase in treatment medications for at least 30 days preceding study entry.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multi
escalating in increments of 2.5 mCi/m2
Biological: 90Y-hLL2
weekly dosing for either 2 or 3 weeks
Other Names:
  • epratuzumab
  • hLL2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation
Time Frame: First 12 weeks, total 5 years
First 12 weeks, total 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine maximum tolerated dose (MTD)
Time Frame: first 12 weeks
first 12 weeks
Evaluate the immunogenicity and safety of repeated infusions of 90Y-hLL2 in NHL patients.
Time Frame: 6 weeks, 12 weeks, every 3 months if HAHA elevated
6 weeks, 12 weeks, every 3 months if HAHA elevated
Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.
Time Frame: 6 wks, 12 wks, every 3 mos for 5 years
6 wks, 12 wks, every 3 mos for 5 years

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

August 1, 2002

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimate)

January 12, 2007

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-T-hLL2-06EU

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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