NCT01207076

AHN-12 Biodistribution in Advanced Leukemia

Phase I Open Label, Single Arm, Dose Escalation Trial to Evaluate the Biodistribution and Safety of AHN-12 In Patients With Advanced Leukemia HM2010-05

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 achieved and the patient remains negative for HAMA, the infusion may be repeated up to two more times (with a one level increase in nonradiolabeled AHN-12 each time) in an attempt of achieving favorable biodistribution. In order to achieve the primary objective of identifying the optimal nonradiolabeled dose of AHN-12 antibody for all patients, if the first patient at the current antibody dose does not achieve favorable biodistribution, the next patient(s) will be treated at the next higher dose level. Patients achieving favorable biodistribution and remaining negative for HAMA will be eligible for the therapeutic component of this trial. Those not meeting these requirements will be taken off study and followed.

Conditions

• Acute Myelogenous Leukemia
• Myelodysplastic Syndrome
• Acute Lymphoblastic Leukemia
• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-09-22
• Last updated: 2017-12-05

Locations

1 site across 1 country: United States