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Yttrium Y 90 Anti-CD19 Antibody BU-12 in Patients With Advanced Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Lymphocytic Leukemia

Leukemia Clinical Trial

Official title:
Phase I Open Label, Single Arm Escalation Trial to Evaluate the Biodistribution and Safety of BU-12 in Patients With Advanced Leukemia

Clinical Trial Summary

RATIONALE: Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. This may be effective treatment for leukemia.

PURPOSE: This phase I trial is studying the best dose of yttrium Y 90-labeled monoclonal antibody BU-12 in treating patients with advanced relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia.

Clinical Trial Description

OBJECTIVES:

Primary

- To determine the biodistribution of indium-111 BU-12 in patients with refractory CD19+ leukemia.

Secondary

- To determine the maximum tolerated dose of yttrium Y 90 anti-CD19 antibody BU-12

- Determine the human anti-mouse antibody (HAMA) response.

- To define, preliminarily, the antitumor activity of yttrium Y 90 anti-CD19 antibody BU-12.

OUTLINE: Patients receive yttrium Y 90 anti-CD19 antibody BU-12/indium-111 BU-12 IV over 60 minutes on day 0 and undergo whole-body imaging on days 0, 1, 3, 4, and 7. Patients also undergo blood collection and bone marrow biopsy periodically for dosimetry calculations and pharmacokinetics.

After completion of study treatment, patients are followed periodically for 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00643240
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact
Status Terminated
Phase Phase 1
Start date January 2008
Completion date April 2010
View Details
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