Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061425
• Other study ID #: IM-T-hLL2-06-EU
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2000

Study information

• Verified date: January 2009
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.)

• Measureable via CT, with at least one lesion > or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.)

• Radiological studies (ie - CT) must be performed within 4 weeks prior to study start.

• Acceptable tumor burden that will allow adequate follow-up and evaluation.

• Less that 25% bone marrow involvement, determined by bone marrow biopsy.

• Must observe the following washout periods:

At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.

At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.

• Must have Karnofsky score >70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months.

• Serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min.

• Serum bilirubin < or = 2mg/dl.

• Hemoglobin > or = 10 g/dl; WBC > or = 3000/mm3; granulocyte count > or = 150/mm3; platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.

• Immunomedics ELISA assay of HahLL2 < 100ng/ml for those with prior history of monoclonal antibody infusions.

• Cognizant informed consent.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• radiolabeled epratuzumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences