Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy

Study Overview
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Brief Summary
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Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen. If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft. 6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated. The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.

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

Conditions
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Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome

Intervention / Treatment
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* Biological: recwt1-A10+AS01B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 and younger than 65 years. Karnofsky ≥ 70 %. 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. Patients in morphologic complete remission at the time of transplantation. WT1 expression detectable on tumor cells. Expected life duration more than 6 months. Creatinine clearance ≥ 50 ml/min Bilirubinemia < 1.5N and ASAT < 2.5N. 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). Membership of a social security scheme or beneficiary of such a regime. Signed inform consent. Exclusion Criteria: Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (>0.3 mg/kg/j) and/or Mycophenolate mofetil. Pregnant or lactating women. HIV seropositive patients. Autoimmune disease (Lupus, multiple sclerosis, Chron disease…) Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy. Patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol. Previous history of another cancer, except if considered as probably cured by the investigator. Patients deprived of liberty, or under guardianship.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immune therapy<br>6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11. | Biological: recwt1-A10+AS01B<br> <br> * Other names: immune therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | Dose limit toxicity (adverse event according to CTCAE V4.0) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune response | The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml. | up to 60 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, allograft, WT1 expression