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

Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT00054834
Collaborator
(none)
27
Enrollment
2
Locations
13.5
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: hLL2 (epratuzumab)
 Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
Study Start Date :
Mar 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 > 1.5x109/L; Platelets > 100x109/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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fox Chase Cancer Center Philadelphia Pennsylvania United States
    2 MD Anderson Cancer Center Houston Texas United States

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00054834
    Other Study ID Numbers:
    • IM-T-hLL2-14
    First Posted:
    Feb 13, 2003
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Jan 1, 2008
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Epratuzumab

    Study Results

    No Results Posted as of Aug 16, 2021