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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03572-51 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Institut de Cancérologie de la Loire | OTHER |
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This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.
Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLA-mismatched micro-transplantation | Experimental | HLA-mismatched micro-transplantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLA-mismatched micro-transplantation after induction chemotherapy | Other | HLA-mismatched micro-transplantation after induction chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of overall survival | Rate of overall survival will be reported. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hematopoietic recovery | Number of platelets will be reported. | 3 months |
| Hematopoietic recovery | Number of neutrophils will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérôme Cornillon, MD | Contact | 04 77 91 67 26 | +33 | jerome.cornillon@chu-st-etienne.fr |
| Elisabeth Daguenet, PhD | Contact | 04 77 91 70 89 | +33 | elisabeth.daguenet@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jérôme Cornillon, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Estaing | Recruiting | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 3 months |
| Hematopoietic recovery | Percentage of leukaemic blasts will be reported. | 3 months |
| Rate of complete remission | Rate of complete remission : | 2 years |
| GVHD (graft versus host disease) | Presence of graft versus host disease will be reported. | 2 years |
| Median overall survival | Median overall survival will be calculated. | 2 years |
| Median progression-free survival | Median progression-free survival will be calculated. | 2 years |
| Microchimerism | Presence of microchimerism will be reported. | 3 months |
| Centre Hospitalier Universitaire de Grenoble | Recruiting | Grenoble | France |
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| CHRU de Lille | Not yet recruiting | Lille | France |
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| Centre Hospitalier Lyon Sud | Recruiting | Lyon | France |
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| Centre Hospitalier Universitaire de Nancy | Not yet recruiting | Nancy | France |
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| Hôpital de la Pitié-Salpêtrière | Not yet recruiting | Paris | France |
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| CHU de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |