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

Stopped early · Phase 1

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT00643240

Run by

Masonic Cancer Center, University of Minnesota

People needed

1

Starts

2008-01-01

Expected to finish

2010-04-01

Last updated by the study team

2017-11-29

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 attempt)
• 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

You may not qualify if…

• 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 requirements
• 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

Where it is running

• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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