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AHN-12 Biodistribution in Advanced Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01207076
Recruitment Status : Terminated (Slow accrual)
First Posted : September 22, 2010
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Biological: 90Y-AHN-12 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: receiving AHN-12 and 90Y-AHN-12
Patients receiving nonradiolabeled cold 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).
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.

Primary Outcome Measures :
  1. Optimal Dose of AHN-12 Non-radiolabeled Antibody [ Time Frame: Day 2 ]
    doses of nonradiolabeled antibody are specified: 0.20, 0.40, 0.60, 0.80 and 1.00 mg/kg.

Secondary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of 90Y-AHN-12 [ Time Frame: Within 14 days of achieving favorable biodistribution ]
    •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.

  2. Human Anti-Mouse Antibody (HAMA) Response [ Time Frame: 30 and 90 Days Post Therapy, Then Every 6 Months If Positive ]
    Event is whether or not the patient develops a HAMA response.

  3. Anti-tumor Activity of 90Y-AHN-12 [ Time Frame: 30 and 90 Days Post Therapy ]
    Event is response to therapy: complete remission, partial remission, refractory or relapsed disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01207076

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United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
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Principal Investigator: Linda Burns, M.D. Masonic Cancer Center, University of Minnesota
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Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT01207076    
Other Study ID Numbers: 2010LS030
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Keywords provided by Masonic Cancer Center, University of Minnesota:
CD45+ disease
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders