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Wilms' Tumor (WT1) Antigen-targeted Dendritic Cell Vaccination to Prevent Relapse in Patients Older Than 65 Years With Acute Myeloid Leukemia: a Multicenter Randomized Phase II Trial

Phase 2
65 Years
Not Enrolling
Acute Myeloid Leukemia

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Trial Information

Wilms' Tumor (WT1) Antigen-targeted Dendritic Cell Vaccination to Prevent Relapse in Patients Older Than 65 Years With Acute Myeloid Leukemia: a Multicenter Randomized Phase II Trial

Together with the Transplant Committee of the Belgian Hematological Society (BHS), we will
perform a multicenter randomized open-label phase II clinical study in 138 patients with
acute myeloid leukemia (AML). Patients older than 65 years who are in complete hematological
remission will be randomized to be vaccinated with dendritic cells or to receive regular
follow-up care. The primary aim of this innovative immunotherapeutic study is to determine
whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a
large cohort of patients and whether dendritic cell vaccination can significantly prevent
relapse and increase survival of AML patients by eradicating minimal residual disease.

Patients will be recruited at 8 different centers in Belgium. Recruitment will start in the
second half of 2012 and will last for three years or until 138 efficacy-evaluable AML
patients are included. In the interventional group, 69 patients will be treated during two
years with autologous dendritic cells loaded by messenger RNA electroporation with the
Wilms' tumor antigen (WT1). The dendritic cell therapy product will be generated and
generally administered in the coordinating center, which is the Antwerp University Hospital,
more specifically the Center for Cell Therapy and Regenerative Medicine (CCRG) and the
Division of Hematology, both headed by Prof. Zwi Berneman. After inclusion of 138
efficacy-evaluable patients, relapse rate, relapse-free survival and overall survival
analysis will be performed. Tumor marker levels and immune activation will also be monitored
to compare the 2 groups at a molecular and immunological level.

Inclusion Criteria:

- Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World
Health Organization (WHO).18

- all French-American-British (FAB) subtypes, except:

- M3 (acute promyelocytic leukemia)

- all cases of de novo AML or secondary AML with ≥ 20 % blasts in peripheral blood
and/or bone marrow, except:

- AML secondary to myeloproliferative neoplasms (MPN)

- AML secondary to exposure of leukemogenic agents (t-AML).

- WT1 transcript levels in peripheral blood and/or bone marrow increased above
background at the time of diagnosis, as determined by qRT-PCR.

- Completion of at least one cycle of induction chemotherapy and one cycle of
consolidation chemotherapy resulting in:

- morphological complete remission (CR), i.e. bone marrow blast count <5% with
neutrophil count >1000 cells/µL and platelet count >100,000 cells/µL.


o morphological complete remission with incomplete blood recovery (CRi), i.e. bone marrow
blast count <5% with neutrophil count <1000 cells/µL or platelet count <100,000 cells/µL.

For the purpose of this study protocol, platelet count must be >50,000 cells/µL.

- Interval between the completion of the last chemotherapy administration and the start
of vaccination (or the start of follow-up in case of the control arm): 6 weeks
(minimum) and 16 weeks (maximum).

- Age: >65 years at the time of enrollment.

- WHO performance status: grade 0 or 1 at the time of enrollment. For definition of
performance status, see:

- Absence of any psychological, familial, sociological, geographical or physical
condition potentially hampering compliance with the study protocol and follow-up
schedule; those conditions should be discussed with the patient before study entry.

Exclusion Criteria:

- Participation in any other interventional clinical trial during the study period.

- History or concomitant presence of any other malignancy, except for:

- non-melanoma skin cancer

- carcinoma in situ of the cervix

- any other effectively treated malignancy that has been in remission for >5 years
or that is highly likely to be cured at the time of enrollment.

- Concomitant presence of any immunosuppressive disease (e.g. HIV) or any active
autoimmune condition, except for vitiligo.

- Concomitant use of systemic corticosteroids in immunosuppressive doses (>1 mg/kg/day
of prednisone, or equivalent dose for other corticosteroid preparations) or any other
immunosuppressive agent. A minimum of 4 weeks must have elapsed between the last dose
of immunosuppressive therapy and the first vaccination. Topical corticosteroids are
permitted, except if applied at the sites of DC injection.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse rate

Outcome Description:

The primary objective of this randomized phase II clinical study is to determine the effect of WT1-targeted dendritic cell vaccination on relapse rate in AML patients older than 65 years and in complete remission.

Safety Issue:


Principal Investigator

Zwi Berneman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Antwerp


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

October 2012

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • in complete remission
  • older then 65 years
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid