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

This study has been terminated.

(lack of accrual)

Sponsor:

Information provided by:

Immunomedics, Inc.

ClinicalTrials.gov Identifier:

NCT00054834

First received: February 11, 2003

Last updated: January 8, 2008

Last verified: January 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 11, 2003
Last Updated Date	January 8, 2008
Start Date ^ICMJE	March 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00054834 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma
Official Title ^ICMJE	A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non-Hodgkins Lymphoma
Intervention ^ICMJE	Drug: hLL2 (epratuzumab)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	27
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00054834
Other Study ID Numbers ^ICMJE	IM-T-hLL2-14
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Immunomedics, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Immunomedics, Inc.
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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