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| Name | Class |
|---|---|
| TC Biopharm | INDUSTRY |
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The Royal Marsden NHS Foundation Trust is committed to improving patient experience; this research is being undertaken to try to develop a novel treatment for patients with Acute Myeloid Leukaemia (AML). Researchers aim to develop a new therapy which uses a patient's own immune cells called T cells to treat AML. In this study, numbers and properties of T cells which can be collected from the blood of patients with AML at various points throughout their treatment will be investigated. Blood samples will be collected at the same time as the patient's bone marrow test.
If patients need further bone marrow tests during their course of treatment to assess the status of disease, the research team would ask that additional samples are taken at the same time as the bone marrow and blood will be collected at the same time as the routine blood draw.
Following collection of blood samples, they will be used to purify a population of blood cells called Gamma Delta T cells which have been shown to have a potential role in control of cancers. In addition the researchers plan to determine whether it is possible to put a novel receptor called a chimeric antigen receptor (CAR) to potentially directly target leukaemia cells. Currently this is only an exploratory study and none of the samples collected will be used for treatment and is only to assess whether or not this strategy is feasible. This may however lead on to studies in the future looking at the safety and effectiveness of this strategy. This hopefully will lead in the future to improvements in treatment and outcome for patients with AML.
If patients need further bone marrow tests during their course of treatment to assess the status of disease, the research team would ask that additional samples are taken at the same time as the bone marrow and blood will be collected at the same time as the routine blood draw.
Following collection of blood samples, they will be used to purify a population of blood cells called Gamma Delta T cells which have been shown to have a potential role in control of cancers. In addition the researchers plan to determine whether it is possible to put a novel receptor called a chimeric antigen receptor (CAR) to potentially directly target leukaemia cells. Currently this is only an exploratory study and none of the samples collected will be used for treatment and is only to assess whether or not this strategy is feasible. This may however lead on to studies in the future looking at the safety and effectiveness of this strategy. This hopefully will lead in the future to improvements in treatment and outcome for patients with AML.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute myeloid leukaemia | Patients with Acute Myeloid Leukaemia (excluding M3) at presentation, remission or with refractory or relapsed disease. There is no intervention. This is an observational tissue collection study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection and bone marrow aspirate | Procedure | Blood and bone marrow samples will be collected for the trial alongside routine tests. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage viable gamma delta T cells | % of viable Vd2g T cells that can be generated from peripheral blood and bone marrow samples from AML patients at diagnosis and in AML patients with relapsed/refractory disease | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Transduced cells | % of Vd2g T cells transduced with a CAR. | 6 months |
| Target AML cells killed | % of target AML cells killed by Gamma Delta CAR-T cells |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed AML or relapsed/refractory AML
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ms C McCormack | Contact | 020 8661 3202 | chloe.mccormack@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Emma Nicholson | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | Recruiting | Sutton | SM2 5PT | United Kingdom |
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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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| 6 months |
| Target monocytes killed | % of target monocytes killed by Gamma Delta Car T cells | 6 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |