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

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
IL-12
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Princess Margaret Centre CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IL-12

Arm Description

A single dose of IL-12, given intravenously.

Outcomes

Primary Outcome Measures

Number of side effects by type and severity

Secondary Outcome Measures

Levels of IL-12
Levels of acute myeloid leukemia (AML)
Length of time patient is alive

Full Information

First Posted
June 24, 2015
Last Updated
September 12, 2023
Sponsor
University Health Network, Toronto
Collaborators
Ozmosis Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02483312
Brief Title
A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
Official Title
Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Ozmosis Research Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IL-12
Arm Type
Experimental
Arm Description
A single dose of IL-12, given intravenously.
Intervention Type
Biological
Intervention Name(s)
IL-12
Primary Outcome Measure Information:
Title
Number of side effects by type and severity
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Levels of IL-12
Time Frame
1 day
Title
Levels of acute myeloid leukemia (AML)
Time Frame
1 day
Title
Length of time patient is alive
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Minden, M.D.
Phone
416-946-2838
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Minden, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Centre Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Minden, M.D.
Phone
416-946-2838
First Name & Middle Initial & Last Name & Degree
Mark Minden, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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