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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2005-000806-29 | |||
| GTAC GTAC098 |
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| Name | Class |
|---|---|
| Department of Health | AMBIG |
| Leukemia Research Fund | OTHER |
| Elimination of Leukaemia Fund | OTHER |
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The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine' in patients with poor prognosis acute myeloid leukaemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Experimental | AML Cell Vaccine alone |
|
| cohort 2 | Experimental | Donor leukocytes alone |
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| cohort 3 | Experimental | AML cell vaccine and Donor Leukocyte Infusion (1x107/kg) |
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| cohort 4 | Experimental | AML cell vaccine and Donor Leukocyte Infusion (1x108/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFUSIN2-AML1 | Biological | AML cell vaccine alone. x4 doses 3 weeks apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity and safety of the 'AML Cell Vaccine' | one year |
| Measure | Description | Time Frame |
|---|---|---|
| relapse, leukaemia free survival and overall survival | one year |
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Inclusion Criteria:
Performance status of 1 or less by ECOG criteria or >80% by the Karnovsky score
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghulam J Mufti | Contact | +44 2032999000 | 3080 | ghulam.mufti@kcl.ac.uk |
| Wendy Ingram | Contact | +44 2032999000 | 4642 | wendy.ingram@kch.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ghulam J Mufti | King's College London, London, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital NHS Foundation Trust | Recruiting | London | London | SE5 9RS | United Kingdom |
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| Donor leukocyte infusion (DLI) |
| Biological |
1 dose 1x107/kg |
|
|
| RFUSIN2-AML1 and donor leukocyte infusion | Biological | AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose |
|
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| RFUSIN2-AML1 and donor leukocyte infusion | Biological | AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose |
|
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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