Yttrium Y 90 Anti-CD45 Monoclonal Antibody AHN-12 in Treating Patients With Advanced Leukemia

Stopped early · Phase 1

Conditions studied: Leukemia, Myelodysplastic Syndromes

In brief

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 monoclonal antibody, can find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. 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.

Key facts

Study ID: NCT00618696
Run by: Masonic Cancer Center, University of Minnesota
People needed: 4
Starts: 2005-07-01
Expected to finish: 2007-12-01
Last updated by the study team: 2017-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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