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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Adverse events at 6 months

Safety Issue:

Yes

Principal Investigator

Christian Chabannon, MD, PhD

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

United States: Federal Government

Study ID:

CDR0000626786

NCT ID:

NCT00963521

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute monocytic leukemia (M5b)
  • adult acute myeloid leukemia in remission
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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