Clinical Trial: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR

Brief Summary: Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete remission (CR).

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: Adverse events [ Time Frame: 6 weeks ]

Primary objective: assess the tolerability of autologous apoptotic corps pulsed dendritic cells vaccine in acute myelogenous leukemia patients in first or second Complete remission. (CR2)


Original Primary Outcome: Adverse events [ Time Frame: 6 weeks ]

Primary objective: assess the tolerability of autologous apoptotic corps pulsed dendritic cells vaccine in in acute myelogenous leukemia patients in second Complete remission. (CR2)


Current Secondary Outcome:

  • immune response [ Time Frame: Day 14 ]
  • Complete remission [ Time Frame: 18 months ]
  • Survival [ Time Frame: 18 months after injection ]
    Overall survival (from the documentation of the second RC)


Original Secondary Outcome:

Information By: Nantes University Hospital

Dates:
Date Received: June 16, 2010
Date Started: November 2009
Date Completion: April 2017
Last Updated: July 25, 2016
Last Verified: December 2015