Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
INTERVENTIONAL
2000-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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radiolabeled epratuzumab
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Principal Investigators
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William Wegener
Role: STUDY_DIRECTOR
Gilead Sciences
Other Identifiers
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IM-T-hLL2-06-EU
Identifier Type: -
Identifier Source: org_study_id
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