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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Biological: IL-12


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IL-12<br>A single dose of IL-12, given intravenously. | Biological: IL-12<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of side effects by type and severity |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of IL-12 |  | 1 day | 
| Levels of acute myeloid leukemia (AML) |  | 1 day | 
| Length of time patient is alive |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent