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

Institut Paoli-Calmettes

Status and phase: Completed; Phase 1

Conditions: Leukemia

Treatments: Biological: therapeutic autologous dendritic cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00963521

CDR0000626786

INCA-RECF-0628

IPC-2006-011

IPC-LADC

EUDRACT-2006-007093-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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