Status:
TERMINATED
Yttrium Y 90 Anti-CD45 Monoclonal Antibody AHN-12 in Treating Patients With Advanced Leukemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as yttrium Y 90 monoclona...
Detailed Description
OBJECTIVES: 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 ...
Eligibility Criteria
Inclusion
- Histologically confirmed CD45+ diseases:
- 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
- Bone marrow cellularity \< 15%
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00618696
Start Date
July 1 2005
End Date
December 1 2007
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