Status:
TERMINATED
AHN-12 Biodistribution in Advanced Leukemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
A dose escalation schema will be used with the initial patient receiving the current lowest dose of nonradiolabeled AHN-12 (from 0.20 mg/kg to 1.0 mg/kg). If a favorable biodistribution is not achieve...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01207076
Start Date
December 1 2013
End Date
July 1 2014
Last Update
December 5 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455