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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963521
• Other study ID #: CDR0000626786
• Secondary ID: IPC-2006-011INCA
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2009
• Last updated: May 12, 2011
• Start date: June 2008

Study information

• Verified date: May 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Biological:
• therapeutic autologous dendritic cells

Locations

Country	Name	City	State
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events at 6 months			Yes