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

Phase 1

Completed

• Conditions: Leukemia

• Registration Number: NCT00963521
• Lead Sponsor: Institut Paoli-Calmettes

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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events at 6 months

Trial Locations

Locations (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France