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

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ClinicalTrials.gov Identifier: NCT00054834
Recruitment Status : Terminated (lack of accrual)
First Posted : February 13, 2003
Last Update Posted : January 9, 2008
Information provided by:
Immunomedics, Inc.

February 11, 2003
February 13, 2003
January 9, 2008
March 2003
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Complete list of historical versions of study NCT00054834 on ClinicalTrials.gov Archive Site
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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.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkins Lymphoma
Drug: hLL2 (epratuzumab)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Immunomedics, Inc.
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Immunomedics, Inc.
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP