NCT00718250

Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
BIOLOGICAL	RFUSIN2-AML1	AML cell vaccine alone. x4 doses 3 weeks apart
BIOLOGICAL	Donor leukocyte infusion (DLI)	1 dose 1x107/kg
BIOLOGICAL	RFUSIN2-AML1 and donor leukocyte infusion	AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
BIOLOGICAL	RFUSIN2-AML1 and donor leukocyte infusion	AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-05-01
• Completion: 2012-02-01
• First posted: 2008-07-18
• Last updated: 2008-07-18

Locations

1 site across 1 country: United Kingdom