TheranosticTrials.org

Clinical Trial · NCT00643240

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

Overview

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.

Sponsor

Masonic Cancer Center, University of Minnesota

Phase

Phase 1

Contacts

Brenda Weigel, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00643240

Drug / Compound

BU-12

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies

BU-12

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies

Eligibility

Inclusion

  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • Oxygen saturation on room air \> 92% and no oxygen requirement
  • Histologically confirmed CD19-positive (\> 25% by flow cytometry evaluation of bone marrow blasts) disease of 1 of the following types:
  • Not pregnant or nursing
  • Negative pregnancy test
  • Life expectancy \> 8 weeks
  • Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
  • Chronic Lymphocytic leukemia (CLL) following blast crisis (≥15% bone marrow blasts following a minimum of one standard effective chemotherapy induction attempt)
  • LVEF ≥ 45% by MUGA/ECHO
  • Patients who have relapsed ≥ 60 days following an autologous or allogeneic transplant are eligible if all other eligibility criteria are met
  • No active central nervous system (CNS) disease
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Fertile patients mus use effective contraception
  • Primary refractory or relapsed acute lymphoblastic leukemia (ALL) defined as persistent disease following a minimum of two different standard effective chemotherapy induction attempts at time of diagnosis or at relapse
  • AST and ALT ≤ 2.5 times ULN
  • Human anti-mouse antibody (HAMA) must be negative

Exclusion

  • HIV-positive
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to of yttrium Y 90 anti-CD19 antibody BU-12 or other agents used in study
  • Less than 3 months since prior antibody or biologic anticancer therapy (e.g., alemtuzumab or epratuzumab)
  • Uncontrolled illness including, but not limited to, any of the following:
  • Less than 7 days since prior therapy with any biologic agent, defined as a growth factor or cytokine
  • Less than 4 weeks since prior agents and recovered
  • Patients with peripheral blasts \> 5,000/uL may receive concurrent hydroxyurea
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Other concurrent investigational agents
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Active graft-vs-host disease