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)
This study is currently recruiting participants.
Verified June 2008 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01146262
First received: June 16, 2010
Last updated: May 11, 2011
Last verified: June 2008
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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
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 Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013