Know Cancer

forgot password

Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches

Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome

Thank you

Trial Information

Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches

Inclusion Criteria:

1. Patients older than 18 and younger than 65 years.

2. Karnofsky ≥ 70 %.

3. Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who
underwent allogeneic stem cell transplantation from HLA-identical donor (related or
unrelated) after reduced-intensity conditioning regimen.

4. Patients in morphologic complete remission at the time of transplantation.

5. WT1 expression detectable on tumor cells.

6. Expected life duration more than 6 months.

7. Creatinine clearance ≥ 50 ml/min

8. Bilirubinemia < 1.5N and ASAT < 2.5N.

9. Women of childbearing age: negative pregnancy test and effective contraception for at
least 30 days before vaccinal immunotherapy (the same contraceptive method must be
continued at least 2 months after the last vaccine infusion).

10. Membership of a social security scheme or beneficiary of such a regime.

11. Signed inform consent.

Exclusion Criteria:

1. Patients with severe and uncontrolled affections, especially active graft-versus-host
disease requiring steroid treatment (>0.3 mg/kg/j) and/or Mycophenolate mofetil.

2. Pregnant or lactating women.

3. HIV seropositive patients.

4. Autoimmune disease (Lupus, multiple sclerosis, Chron disease…)

5. Previous history of allergic state which could be potentially compound by a component
of the vaccinal immunotherapy.

6. Patients who received (or are planned to receive) another experimental treatment
within 30 days following the first infusion of the experimental drug of this

7. Previous history of another cancer, except if considered as probably cured by the

8. Patients deprived of liberty, or under guardianship.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Dose limit toxicity (adverse event according to CTCAE V4.0)

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

ALLO-WT1/IPC 2011-006



Start Date:

March 2013

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplastic Syndrome
  • acute myeloid leukemia
  • chronic myeloid leukemia
  • myelodysplastic syndrome
  • allograft
  • WT1 expression
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia