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

Phase 1

Terminated

• Conditions: Non-Hodgkins Lymphoma

• Registration Number: NCT00054834
• Lead Sponsor: Gilead Sciences

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 available

Study Timeline

• Study First Submitted: 2003-02-11
• Study First Submitted QC: 2003-02-12
• Study First Posted: 2003-02-13
• Study Start: 2003-03
• Status Verified: 2008-01
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (2)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States