Yttrium Y 90 Anti-CD45 Monoclonal Antibody AHN-12 in Treating Patients With Advanced Leukemia
NCT ID: NCT00618696
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2005-07-31
2007-12-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90 monoclonal antibody and how much radiation is taken in by the organs in the body in treating patients with advanced leukemia or other hematologic disorder.
Detailed Description
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Primary
* To establish that a dose of 150 mg/m² of nonradiolabeled anti-CD45 monoclonal antibody AHN-12 results in normal biodistribution, normal-organ estimated radiation-absorbed dose of less than 20 Gy, and estimated radiation-absorbed dose of no more than 13 Gy to the red marrow.
Secondary
* To determine the maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12).
* To determine the human anti-mouse antibody (HAMA) response.
* To define, preliminarily, the antitumor activity of \^90Y-AHN-12.
OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12).
* Biodistribution: Patients receive nonradiolabeled monoclonal antibody AHN-12 IV and an imaging dose of indium Y 111 monoclonal antibody AHN-12 (\^111In-AHN-12) IV over 10 minutes on day 0. Patients undergo whole-body gamma-camera imaging immediately following infusion, at 4-6 hours, and on days 1, 3, 4, and 7. Blood samples are collected prior to each imaging for dosimetry calculations and pharmacokinetics.
Patients also undergo bone marrow biopsy 16-24 hours after infusion for dosimetry calculations. Patients with the expected biodistribution of \^111In-AHN-12, an estimated radiation-absorbed dose to the normal organ of \< 20 Gy, an estimated radiation-absorbed dose to the red marrow of ≤ 13 Gy, and a negative human anti-mouse antibody at day 7 proceed to the therapy portion.
* Treatment: Patients receive nonradiolabeled anti-CD45 monoclonal antibody AHN-12 IV over 60 minutes and escalating therapy doses of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12) IV over 10 minutes on day 7 or 8.
After completion of study treatment, patients are followed periodically for 1 year.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AHN-12
2.0, 5.0, 7.5, 10.0 or 12.5 mCi/m\^2 of \^90Y-AHN-12 at Day 7/8
anti-CD45 monoclonal antibody AHN-12
150 mg/m\^2 cold antibody at Day 0
yttrium Y 90 anti-CD45 monoclonal antibody AHN-12
Dose per scheduled level; 2.5-12.5 mCi/m\^2
Interventions
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anti-CD45 monoclonal antibody AHN-12
150 mg/m\^2 cold antibody at Day 0
yttrium Y 90 anti-CD45 monoclonal antibody AHN-12
Dose per scheduled level; 2.5-12.5 mCi/m\^2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute lymphoblastic leukemia or acute myeloid leukemia (AML), meeting any of the following criteria:
* Primary refractory disease
* Relapsed disease, defined as persistent disease following a minimum of 2 different standard chemotherapy induction attempts at time of diagnosis or at relapse
* Acute myelogenous leukemia (AML), primary refractory or relapsed disease - defined as persistent disease after a minimum of two different standard chemotherapy induction attempts at time of diagnosis or relapse
* Advanced myelodysplastic syndrome (MDS) defined as \> or = 15% bone marrow blasts following a minimum of one standard chemotherapy induction attempt
* AML arising from preexisting MDS, refractory - defined as persistent disease following a minimum of one standard chemotherapy induction attempt
* Chronic myelogenous leukemia (CML) following blast crisis (\> or = 15% marrow blasts following a minimum of one standard chemotherapy induction attempt
* Peripheral leukemic blasts (by morphology) must be \< 5,000/μL (hydroxyurea to control peripheral blast count allowed)
* Must have source of allogeneic stem cells (sibling, unrelated cord\[s\], or donor) identified prior to initiation of protocol therapy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
* aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.3 mg/dL OR creatinine clearance ≥ 60 mL/min
* Left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram (ECHO)
* Carbon Monoxide Diffusing Capacity (DLCO) (corrected) ≥ 50% of predicted
* Human anti-mouse antibody (HAMA) must be negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Human immunodeficiency virus (HIV) negative
* Recovered from all prior therapy
* At least 7 days since prior biologic agents
Exclusion Criteria
* Known brain metastases or active central nervous system (CNS) disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to \^90Y-AHN-12 or other agents used in study
* Uncontrolled illness, including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic or congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would limit compliance with study requirements
* Other concurrent investigational agents
* Prior allogeneic transplantation
* Less than 60 days since prior autologous transplantation with relapsed disease
18 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Masonic Cancer Center, University of Minnesota
Principal Investigators
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Linda J. Burns, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-MT2005-13R
Identifier Type: OTHER
Identifier Source: secondary_id
2005LS039
Identifier Type: -
Identifier Source: org_study_id