- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00963521
Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Marseille, France, 13273
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adverse events at 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Christian Chabannon, MD, PhD, Institut Paoli-Calmettes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- 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)
- adult acute myeloid leukemia in remission
- adult acute monoblastic leukemia (M5a)
- adult acute monocytic leukemia (M5b)
- adult acute myelomonocytic leukemia (M4)
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000626786
- IPC-2006-011
- INCA-RECF-0628
- EUDRACT-2006-007093-29
- IPC-LADC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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