AHN-12 Biodistribution in Advanced Leukemia

Stopped early · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

In brief

This study is a single institution phase I study for the treatment of patients with relapsed or refractory leukemia aged 12 years and older using 90Y-AHN-12.

Key facts

Study ID

NCT01207076

Run by

Masonic Cancer Center, University of Minnesota

People needed

8

Starts

2013-12-01

Expected to finish

2014-07-01

Last updated by the study team

2017-12-05

Who can join

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

You may qualify if…

• Patients must have one of the following histologically confirmed CD45+ diseases. If possible, AHN-12 positivity will be confirmed by flow cytometry on a recent bone marrow or a peripheral blood sample, if circulating blasts are present.
• Acute myelogenous leukemia (AML), primary refractory or relapsed disease
• Refractory myelodysplastic syndrome (MDS)
• AML arising from pre-existing MDS, refractory
• Acute lymphoblastic leukemia (ALL), primary refractory or relapsed disease
• Chronic myelogenous leukemia (CML) following blast crisis
• Age ≥ 12 years
• Karnofsky Performance Status ≥ 60% (16 years and older) or Lansky Play Score ≥ 60 (<16 years)
• Life expectancy of > 12 weeks in the opinion of the enrolling medical provider
• Patients must have adequate organ function
• Human anti-mouse antibody (HAMA) must be negative (perform on all patients regardless of prior therapies).
• Consent to adequate contraception. The effects of 90Y-AHN-12 on the developing fetus are unknown.
• Source of allogeneic stem cells must have been identified in event of severe myelosuppression
• Able to give written consent.
• Both men and women of all ethnic groups are eligible for this trial.

You may not qualify if…

• Ongoing grade 2 or greater non-hematologic toxicity due to previously administered therapies
• < 8 days from completion of therapy with any biologic agent
• Receiving any investigational agents
• Active central nervous system (CNS) leukemia are excluded from this clinical trial
• 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, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the enrolling medical provider.
• Pregnant and breastfeeding women are excluded from this study because 90Y-AHN-12, being radioactive, as well as high dose chemotherapy and total body irradiation (TBI) have the potential for teratogenic or abortifacient effects.
• Human immunodeficiency virus (HIV) positive patients:
• < 60 days since an autologous transplant
• Bone marrow cellularity <5% (because of concern of myelosuppression)

Where it is running

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

Full record on ClinicalTrials.gov

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