A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02483312|
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : December 12, 2019
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)|
|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|
A single dose of IL-12, given intravenously.
- Number of side effects by type and severity [ Time Frame: 2 years ]
- Levels of IL-12 [ Time Frame: 1 day ]
- Levels of acute myeloid leukemia (AML) [ Time Frame: 1 day ]
- Length of time patient is alive [ Time Frame: 2 years ]
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
|Contact: Mark Minden, M.D.||416-946-2838|
|Princess Margaret Centre Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Mark Minden, M.D. 416-946-2838|
|Principal Investigator: Mark Minden, M.D.|
|Principal Investigator:||Mark Minden, M.D.||Princess Margaret Cancer Centre|