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Sponsors and Collaborators: |
King's College Hospital NHS Trust Department of Health Leukemia Research Fund Elimination of Leukaemia Fund |
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Information provided by: | King's College Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT00718250 |
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).
Condition | Intervention | Phase |
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Leukemia, Myeloid, Acute |
Biological: RFUSIN2-AML1 Biological: Donor leukocyte infusion (DLI) Biological: RFUSIN2-AML1 and donor leukocyte infusion |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Lentivirus Transduced Acute Myeloid Leukaemic Cells (AML) Expressing B7.1 (CD80) and IL-2 for the Potential Enhancement of Graft Versus Leukaemia(GvL) Effect in Poor Prognosis AML |
Estimated Enrollment: | 24 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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cohort 1: Experimental
AML Cell Vaccine alone
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Biological: RFUSIN2-AML1
AML cell vaccine alone. x4 doses 3 weeks apart
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cohort 2: Experimental
Donor leukocytes alone
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Biological: Donor leukocyte infusion (DLI)
1 dose 1x107/kg
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cohort 3: Experimental
AML cell vaccine and Donor Leukocyte Infusion (1x107/kg)
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Biological: RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
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cohort 4: Experimental
AML cell vaccine and Donor Leukocyte Infusion (1x108/kg)
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Biological: RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Performance status of 1 or less by ECOG criteria or >80% by the Karnovsky score
Exclusion Criteria:
Contact: Ghulam J Mufti | +44 2032999000 ext 3080 | ghulam.mufti@kcl.ac.uk |
Contact: Wendy Ingram | +44 2032999000 ext 4642 | wendy.ingram@kch.nhs.uk |
United Kingdom | |
King's College Hospital NHS Foundation Trust | Recruiting |
London, United Kingdom, SE5 9RS |
Principal Investigator: | Ghulam J Mufti | King's College London, London, United Kingdom |
Responsible Party: | King's College Hospital NHS Foundation Trust, London, United Kingdom ( Dr Lorraine Catt, Research and Development Manager ) |
Study ID Numbers: | O5CC14, EudraCT 2005-000806-29, GTAC GTAC098 |
Study First Received: | June 6, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00718250 |
Health Authority: | United Kingdom: Gene Therapy Advisory Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Acute myeloid leukaemia Cancer vaccines Immunotherapy |
Leukemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |