AHN-12 Biodistribution in Advanced Leukemia

NCT01207076 | Terminated Phase 1 DMC

• 1 other identifier: 2010LS030
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia

Keywords

CD45+ disease

Outcome Measures

Primary Outcomes (1)

• Optimal Dose of AHN-12 Non-radiolabeled Antibody

  doses of nonradiolabeled antibody are specified: 0.20, 0.40, 0.60, 0.80 and 1.00 mg/kg.

  Day 2

Secondary Outcomes (3)

• Maximum Tolerated Dose (MTD) of 90Y-AHN-12

  Within 14 days of achieving favorable biodistribution

• Human Anti-Mouse Antibody (HAMA) Response

  30 and 90 Days Post Therapy, Then Every 6 Months If Positive

• Anti-tumor Activity of 90Y-AHN-12

  30 and 90 Days Post Therapy

Study Arms (1)

receiving AHN-12 and 90Y-AHN-12

EXPERIMENTAL

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

Interventions

90Y-AHN-12 BIOLOGICAL

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.

receiving AHN-12 and 90Y-AHN-12

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda Burns, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 5, 2017

Record last verified: 2017-12

Locations

US (1)