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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Lymphoma, B-Cell

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Trial Information

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

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

William Wegener

Investigator Role:

Study Director

Investigator Affiliation:

Immunomedics, Inc.

Authority:

Germany: Federal Institute for Drugs and Medicinal Devices (Paul Erlich Institute)

Study ID:

IM-T-hLL2-06-EU

NCT ID:

NCT00061425

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma, B-Cell
  • NHL
  • recurrent B-cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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