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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01146262
First received: June 16, 2010
Last updated: May 11, 2011
Last verified: June 2008
  Purpose

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).


Condition Intervention Phase
Acute Myelogenous Leukemia
Other: cell therapy product
Procedure: injection of the cell therapy product
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Primary objective: assess the tolerability of autologous apoptotic corps pulsed dendritic cells vaccine in in acute myelogenous leukemia patients in first or second Complete remission. (CR2)


Estimated Enrollment: 15
Study Start Date: November 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: cell therapy product
    Patients receive for up to 5 doses of apoptotic corpse pulsed dendritic cells after CR2 documentation (9/10 subcutaneously and 1/10 intradermally) every week, except the last injection performed at 2 weeks from the 4th injection.
    Procedure: injection of the cell therapy product
    Cytapheresis D0: 1st injection of the cell therapy product, J7 2nd injection of the cell therapy product, J14 third injection of the cell therapy product,J17 cutaneous biopsies, J21 fourth injection of the cell therapy product, J35 fifth injection of the cell therapy product
  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 65-75 years
  • Informed consent signed
  • Serology HIV, hepatitis B, hepatitis C, HTLV 1 and 2 and Syphilis always negative (new achievement tests)
  • Performance Statut <=2
  • Must not be eligible for allogeneic transplantation
  • No progressive disease
  • Bone marrow and/or peripheral blasts >50% before chemotherapyBlasts >=2.4 10*8 (collected prior to chemotherapy) available No contraindication to cytapheresis
  • AML in CR2, except M3-AML
  • Patients with refractory AML after induction treatment and a patient eligible for salvage treatment may allow the production of a first complete remission.
  • Patient with newly diagnosed AML with unfavorable cytogenetics and for whom (which) a course of intensive induction and consolidation treatment for outpatients are possible
  • Patient with newly diagnosed AML with a non-adverse cytogenetics AND either refused to participate in the protocol GOELAMS LAMS-2007, against the exclusion criteria, indicating participation in the protocol GOELAMS LAMS-2007 and for whom (which) a course of induction and intensive outpatient treatment for consolidation are possible

Exclusion Criteria

  • Patients who, for reasons psychological, social or geographical boundaries, could be monitored during the study
  • No infections or visceral (cardiac, lung, brain, ...) serious uncontrolled
  • History of positive allogeneic bone marrow or solid organ transplantation.
  • Previous history of autoimmune disease other than vitiligo
  • History of other cancer, except cervical carcinoma in situ or basal cell carcinoma of the skin unless deemed cured for over 5 years.
  • Inability to collect at the diagnosis of relapsed AML, enough leukemic cells (> 2.4 x108)
  • Inability to collect during remission, a sufficient number of monocytes in two leukapheresis maximum
  • Failure to obtain a maturation of monocytes
  • Patient with AML 3
  • Patient may receive an allogeneic hematopoietic stem cell
  • No treatment related to treatment of molecules in preclinical development underway or completed MA within the last 4 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146262

Contacts
Contact: Chevallier Patrice

Locations
France
Cellule de Promotion de la recherche clinique Recruiting
Nantes, France, 44093
Contact: Anne Omnes    02 53 48 28 35    laetitia.biron@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Dr Patrice Chevallier, CHU de Nantes
ClinicalTrials.gov Identifier: NCT01146262     History of Changes
Other Study ID Numbers: 05/10-L
Study First Received: June 16, 2010
Last Updated: May 11, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Antitumoral immune response after autologous dendritic cells vaccination

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014