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

Phase 1
12 Years
Not Enrolling

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Trial Information

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



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


- 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

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

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

Inclusion Criteria:

- Histologically confirmed CD19-positive (> 25% by flow cytometry evaluation of bone
marrow blasts) disease of 1 of the following types:

- 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

- Chronic Lymphocytic leukemia (CLL) following blast crisis (≥15% bone marrow
blasts following a minimum of one standard effective chemotherapy induction

- Human anti-mouse antibody (HAMA) must be negative

- 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

- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

- Life expectancy > 8 weeks

- Total bilirubin ≤ 2.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- LVEF ≥ 45% by MUGA/ECHO

- Oxygen saturation on room air > 92% and no oxygen requirement

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients mus use effective contraception

Exclusion criteria:

- 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

- Uncontrolled illness including, but not limited to, any of the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study

- HIV-positive

- Active graft-vs-host disease

- Less than 4 weeks since prior agents and recovered

- Less than 7 days since prior therapy with any biologic agent, defined as a growth
factor or cytokine

- Less than 3 months since prior antibody or biologic anticancer therapy (e.g.,
alemtuzumab or epratuzumab)

- Other concurrent investigational agents

- Patients with peripheral blasts > 5,000/uL may receive concurrent hydroxyurea

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biodistribution of indium-111 BU-12

Outcome Description:

Perform a whole body scan acquiring both anterior and posterior images at a speed of 10 cm/min (20 minute scan) using a medium energy collimator, a 256 x 1024 computer acquisition matrix and acquisition photo peak settings of 172 and 247 keV with 15% windows.

Outcome Time Frame:

Immediately post infusion, 4-6 hours after infusion and Days 1, 3, 4 and 7 after infusion

Safety Issue:


Principal Investigator

Brenda Weigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

April 2010

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • refractory chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455