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

Sponsoren

Hauptsponsor: Immunomedics, Inc.

Quelle Immunomedics, Inc.
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum August 2000
Primäres Abschlussdatum November 2007
Phase Phase 1/Phase 2
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: radiolabeled epratuzumab

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
William Wegener Study Director Immunomedics, Inc.
Überprüfungsdatum

January 2009

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov