Status:
TERMINATED
Yttrium Y 90 Anti-CD19 Antibody BU-12 in Patients With Advanced Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Lymphocytic Leukemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia
Eligibility:
All Genders
12+ years
Phase:
PHASE1
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: Th...
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...
Eligibility Criteria
Inclusion
- 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 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
- 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 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00643240
Start Date
January 1 2008
End Date
April 1 2010
Last Update
November 29 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455