Spots Global Cancer Trial Database for Yttrium Y 90 Anti-CD19 Antibody BU-12 in Patients With Advanced Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Lymphocytic Leukemia

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Trial Identification

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

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

Study ID: NCT00643240

Conditions

Leukemia

Interventions

yttrium Y 90 anti-CD19 monoclonal antibody BU12

111In-BU-12

Study Description

Brief 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.