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| Name | Class |
|---|---|
| Ozmosis Research Inc. | INDUSTRY |
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This study aims to determine the safety and toxicity of incremental doses of Double Negative T (DNT) cells in human subjects with high risk acute myeloid leukemia (AML). DNT cells are mature T lymphocytes that comprise ~1% of white blood cells in humans. Injection of DNTs from healthy donors has been demonstrated to be effective against AML cells. DNT cells will be collected from healthy volunteers and injected into patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Arm | Experimental | Patients will receive DNT cells from healthy donors. |
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| Donor Arm | No Intervention | Healthy volunteer donors will donate blood. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNT cells | Biological | DNT cells will be expanded (increased in numbers) in the laboratory, in order to enhance their tumour destroying potential before infusion into AML patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events and abnormal laboratory studies. | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cells with disease specific mutations per patient | Quantitive real time polymerase chain reaction (PCR) analysis for disease specific mutations will be performed on the bone marrow aspirate. | 2 years |
| Leukemia load |
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Patient Inclusion Criteria:
Patients with AML who are 18 years of age or older.
Viably frozen cells from the time of diagnosis or relapse are available for sensitivity testing to DNT cells.
Patients have given informed consent.
Patients in remission following FLAG-Ida induction therapy who are receiving consolidation treatment.
Creatinine < 1.5 x ULN within 7 days prior to day 1 of study treatment.
AST, ALP, bilirubin < 1.5x ULN within 7 days prior to day 1 of study treatment.
Female patients of childbearing potential should be willing to use 2 methods of birth control (Refer to section 9.2.15 or be surgically sterile, or abstain from heterosexual activity for the course of the study from day 1 until 1 months following chemotherapy. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 2 years.
Male patients should use condoms or abstain from sex from the time of beginning chemotherapy to 1 month after the chemotherapy.
Patients must be able to comply with study procedures, at the minimum, until all DNT-UHN-1 cells are out of their system.
Patient Exclusion Criteria:
Donor Inclusion Criteria:
Donor Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G2M9 | Canada |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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.
| 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |