NCT00643240

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
RADIATION	yttrium Y 90 anti-CD19 monoclonal antibody BU12	Patients in whom the biodistribution is as expected (unaltered) AND a HAMA response does not develop will receive a single dose of 90Y-BU-12 in a dose escalated manner to establish the maximum tolerated dose (MTD) of 90Y-BU-12 over 60 minutes on Day 0. A single course of BU-12 includes the imaging dose of 111In-BU-12 followed 7-8 days later by the therapy dose of 90YBU- 12.
RADIATION	111In-BU-12	Patients receive indium-111 BU-12 IV over 60 minutes on day 0

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-03-26
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States