AHN-12 Biodistribution in Advanced Leukemia
NCT01207076 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2017-12-05
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.
Conditions
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
Interventions
- BIOLOGICAL
-
90Y-AHN-12
The intervention consists of two parts. 1. The dose of cold AHN-12 to achieve favorable biodistribution through imaging using 111In-AHN-12. * Dose escalation of nonradiolabeled AHN-12: Dose level= -1 0.20 mg/kg, Dose level=1 0.40 mg/kg, Dose level=2 0.80 mg/kg, Dose level=3 1.20 mg/kg, Dose level=4 1.60 mg/kg, Dose level=5 2.00 mg/kg 2. Phase I therapeutic dosing of cold AHN-12 at dose established plus 90Y-AHN-12. * the starting 90Y-AHN-12 dose level will be 4 Gy with the dose escalated in increments of 4 Gy to a maximum of 20 Gy.
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Linda Burns, M.D. · Masonic Cancer Center, University of Minnesota
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
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