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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00061425

Collaborator

(none)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Lymphoma, B-Cell	Drug: radiolabeled epratuzumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.