Study of Allogeneic Double Negative T Cells (DNT-UHN-1) in Patients With High Risk Acute Myeloid Leukemia
|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: NCT03027102|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : December 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: DNT cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Allogeneic Double Negative T Cells (DNT-UHN-1) in Patients With High Risk Acute Myeloid Leukemia|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Patient Arm
Patients will receive DNT cells from healthy donors.
Biological: DNT cells
DNT cells will be expanded (increased in numbers) in the laboratory, in order to enhance their tumour destroying potential before infusion into AML patients.
No Intervention: Donor Arm
Healthy volunteer donors will donate blood.
- Number of patients with adverse events and abnormal laboratory studies. [ Time Frame: 2 years ]Patients will be assessed for adverse events based upon, but not limited to, monitoring of vital signs and prescribed laboratory studies. Adverse events (AE) will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE). This study will utilize the CTCAE Version 4.03 for adverse event reporting.
- Number of cells with disease specific mutations per patient [ Time Frame: 2 years ]Quantitive real time polymerase chain reaction (PCR) analysis for disease specific mutations will be performed on the bone marrow aspirate.
- Leukemia load [ Time Frame: 2 years ]Peripheral blood will be obtained after DNT cell infusion to monitor leukemia load and residual disease by determining the frequency of leukemic cell markers on cells using flow cytometry.
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): NCT03027102
|Contact: Mark Minden, MDfirstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G2M9|
|Contact: Mark Minden|