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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immune therapy | Experimental | 6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recwt1-A10+AS01B | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| safety | Dose limit toxicity (adverse event according to CTCAE V4.0) | 30 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier BLAISE, MD PhD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli-Calmettes | Marseille | 13009 | France |
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| Label | URL |
|---|---|
| official web site of the sponsor | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| ID | Term |
|---|---|
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |