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Acute Myelogenous LeukemiaPhase 1/2CD lamNCT01146262

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

A Phase 1/2 study testing cell therapy product and injection of the cell therapy product in people with Acute Myelogenous Leukemia, run by Nantes University Hospital at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myelogenous Leukemia
What is being tested?
cell therapy product and injection of the cell therapy product
How many people
5 participants
Where
1 siteFrance
Study dates
Nov 2009to Apr 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60 years
  • Informed consent signed
  • Serology HIV, hepatitis B, hepatitis C, HTLV 1 and 2 and Syphilis always negative (new achievement tests)
  • Performance Statute <=2
  • Must not be eligible for allogeneic transplantation
  • No progressive disease
Show all 12Show fewer
  • 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 out patient treatment for consolidation are possible
  • Absence of donor HLA-compatible family or non-family and absence of placental blood available for performing an allograft.

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Cellule de Promotion de la recherche clinique

    Nantes, 44093

Other trials in France

About this study

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

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).

Being tested
cell therapy product, injection of the cell therapy product
Keywords
Antitumoral immune response after autologous dendritic cells vaccination
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cell therapy productOther

    Patients receive for up to 5 doses of apoptotic corpse pulsed dendritic cells after CR1 ou CR2 documentation (9/10 subcutaneously and 1/10 intradermally) every week, except the last injection performed at 2 weeks from the 4th injection.

  • injection of the cell therapy productProcedure or surgery

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    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)

    Measured: 6 weeks

Secondary outcomes (3)

  1. immune response

    Measured: Day 14

  2. Complete remission

    Measured: 18 months

  3. Survival

    Overall survival (from the documentation of the second RC)

    Measured: 18 months after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionApr 2017 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01146262
Sponsor's protocol ID
BRD/05/10-L
Acronym
CD lam
Status last verified
Dec 2015
First submitted
16 Jun 2010
Last updated
26 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Chevallier P, Saiagh S, Dehame V, Guillaume T, Peterlin P, Bercegeay S, Le Bris Y, Bossard C, Gauvrit I, Dreno B, Juge-Morineau N, Bene MC, Gregoire M. A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients. Hum Vaccin Immunother. 2021 Oct 3;17(10):3511-3514. doi: 10.1080/21645515.2021.1943991. Epub 2021 Jun 21.

    PubMed 34152898

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cell therapy product and injection of the cell therapy product in people with Acute Myelogenous Leukemia, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146262, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.

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