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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00061425
Enrollment
Unknown
Registered
2003-05-28
Start date
2000-08-31
Completion date
Unknown
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

NHL, recurrent B-cell lymphoma

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.

Interventions

DRUGradiolabeled epratuzumab

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026