COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054834
Recruitment Status : Terminated (lack of accrual)
First Posted : February 13, 2003
Last Update Posted : January 9, 2008
Information provided by:
Immunomedics, Inc.

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
Non-Hodgkins Lymphoma Drug: hLL2 (epratuzumab) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
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 : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 > 1.5x10^9/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054834

Layout table for location information
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
Immunomedics, Inc.
Layout table for additonal information Identifier: NCT00054834    
Other Study ID Numbers: IM-T-hLL2-14
First Posted: February 13, 2003    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents