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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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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

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Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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therapeutic autologous dendritic cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No