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

Study Overview
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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.

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.

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

Conditions
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Leukemia

Intervention / Treatment
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* Biological: therapeutic autologous dendritic cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: therapeutic autologous dendritic cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events at 6 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)