AHN-12 Biodistribution in Advanced Leukemia
This study is a single institution phase I study for the treatment of patients with relapsed or refractory leukemia aged 12 years and older. All patients must test negative for the human anti-mouse antibody (HAMA) and remain negative after each infusion to continue on study. In addition, a source of allogeneic stem cells (sibling, unrelated donor or cord) must have been identified in event of severe myelosuppression.
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Optimal Dose of AHN-12 Non-radiolabeled Antibody [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]doses of nonradiolabeled antibody are specified: 0.20, 0.40, 0.60, 0.80 and 1.00 mg/kg.
- Maximum Tolerated Dose (MTD) of 90Y-AHN-12 [ Time Frame: Within 14 days of achieving favorable biodistribution ] [ Designated as safety issue: Yes ]•Determine the MTD of 90Y-AHN-12 for patients with a favorable biodistribution and a negative human anti-mouse antibody (HAMA). Doses of radiolabeled antibody are specified starting dose level with dose increment of 2 gray (Gy) to maximum of 22 Gy.
- Human Anti-Mouse Antibody (HAMA) Response [ Time Frame: 30 and 90 Days Post Therapy, Then Every 6 Months If Positive ] [ Designated as safety issue: No ]Event is whether or not the patient develops a HAMA response.
- Anti-tumor Activity of 90Y-AHN-12 [ Time Frame: 30 and 90 Days Post Therapy ] [ Designated as safety issue: No ]Event is response to therapy: complete remission, partial remission, refractory or relapsed disease.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: AHN-12 Treated Patients
Patients receiving nonradiolabeled 90Y-AHN-12 (.20 mg/kg to 1.0 mg/kg) of at least one dose and up to a total of 3 dosimetry infusions (intervals no sooner than 8 days and up to 21 days).
A dose escalation schema will be used with the initial patient receiving the current lowest dose of nonradiolabeled AHN-12. 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.
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 to two more times (with a one level increase in nonradiolabeled AHN-12 each time) in an attempt of achieving favorable biodistribution.
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.
|Contact: Linda Burns, M.D.||firstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Linda Burns, M.D. 612-624-8144 email@example.com|
|Principal Investigator: Linda Burns, M.D.|
|Principal Investigator:||Linda Burns, M.D.||Masonic Cancer Center, University of Minnesota|