AzTrials
AzTrials

LeukemiaPhase 1NCT00963521

Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission

A Phase 1 study testing therapeutic autologous dendritic cells in people with Leukemia, run by Institut Paoli-Calmettes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia
What is being tested?
therapeutic autologous dendritic cells
How many people
10 participants
Where
1 siteFrance
Study dates
Jun 2008to May 2011
Phase
Phase 1
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myelogenous leukemia (AML)
  • Myelomonocytic (M4) or monocytic (M5) subtype
  • In second complete remission (CR) or later following CR1 lasting ≤ 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation
  • No (15;17) translocation
  • No AML M3
  • HLA-A2 positivity
  • CD14 ≥ 20% on peripheral blood mononuclear cells
  • Circulating blasts ≥ 10 x 109/L (collected prior to chemotherapy) available
  • Must not be eligible for HLA-matched allogeneic transplantation
  • No progressive disease

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No contraindication to cytopheresis or chemotherapy
  • No HIV or HTLV positivity
  • No hepatitis B or C activation
  • No prior psychological disease
  • Not deprived of liberty and able to give consent
  • Must be able to speak and read French
  • No other cancer except for basal cell or cervical

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent participation in another clinical study

Trial locations and contacts

1 site in 1 country.

France1 site

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

Other trials in France

About this study

Official title: Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission

RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

Read the detailed description

OBJECTIVES:

Primary

  • Assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission.

Secondary

  • Evaluate the emergence of an immune response.
  • Determine the relapse rate.
  • Assess the occurrence of residual disease.

OUTLINE: Patients receive increasing doses of blastic cells transformed in vitro by autologous dendritic cells (1/3 subcutaneously and 2/3 IV) every 3 weeks for up to 5 doses.

Conditions
Leukemia
Being tested
therapeutic autologous dendritic cells
Keywords
adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22)
Medical subject headings
Leukemia, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Congenital Abnormalities

What participants receive

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

  • therapeutic autologous dendritic cellsBiological

What is being measured

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

  1. Adverse events at 6 months

Timeline

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

  1. First posted21 Aug 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionMay 2011

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
Primary purpose
Treatment
Allocation
Non-randomised
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00963521
Sponsor's protocol ID
CDR0000626786
Other IDs
IPC-2006-011, INCA-RECF-0628, EUDRACT-2006-007093-29, IPC-LADC
Status last verified
May 2011
First submitted
20 Aug 2009
Last updated
13 May 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing therapeutic autologous dendritic cells in people with Leukemia, run by Institut Paoli-Calmettes 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?

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: finished, as of the sponsor's last update on 13 May 2011. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 at 6 months. 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 NCT00963521.

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 13 May 2011.

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