NCT00963521

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

2.9 years

First QC Date

August 20, 2009

Last Update Submit

May 12, 2011

Conditions

Leukemia

Keywords

adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute monocytic leukemia (M5b)adult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)

Outcome Measures

Primary Outcomes (1)

  • Adverse events at 6 months

Interventions

therapeutic autologous dendritic cellsBIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Marseille, 13273, France

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteCongenital Abnormalities

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemia, Myeloid, AcuteCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christian Chabannon, MD, PhD

    Institut Paoli-Calmettes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

June 1, 2008

Primary Completion

May 1, 2011

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

FR(1)