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A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT02483312
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
Ozmosis Research Inc.
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant.

This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: IL-12 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
Study Start Date : September 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: IL-12
A single dose of IL-12, given intravenously.
Biological: IL-12



Primary Outcome Measures :
  1. Number of side effects by type and severity [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Levels of IL-12 [ Time Frame: 1 day ]
  2. Levels of acute myeloid leukemia (AML) [ Time Frame: 1 day ]
  3. Length of time patient is alive [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with AML and >=18 years of age.
  • Agrees to participate in the study and signs the informed consent
  • Viable cells are available for successful modification
  • First or higher complete remission and have high risk features of relapse.
  • Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment.
  • Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment.
  • Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
  • Agree to use contraception
  • Not pregnant
  • Able to comply with study procedures

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status >2
  • Known persistent infection
  • Known central nervous system (CNS) disease
  • Greater than 10% blasts in the bone marrow or circulating blast cells
  • Life expectancy < 2 months
  • Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine.
  • Patients who are HIV positive.

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 ClinicalTrials.gov identifier (NCT number): NCT02483312


Contacts
Contact: Mark Minden, M.D. 416-946-2838

Locations
Canada, Ontario
Princess Margaret Centre Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Mark Minden, M.D.    416-946-2838      
Principal Investigator: Mark Minden, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Ozmosis Research Inc.
Investigators
Principal Investigator: Mark Minden, M.D. Princess Margaret Cancer Centre

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02483312     History of Changes
Other Study ID Numbers: DDP-IL-12
OZM-068 ( Other Identifier: Ozmosis Research Inc. )
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Keywords provided by University Health Network, Toronto:
Recurrent

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Interleukin-12
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents