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The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Busilvex, Fludara, Thymoglobuline | Active Comparator | D-6: Fludara D-5: Fludara + Busilvex D-4: Fludara + Busilvex D-3: Fludara + Busilvex D-2: Fludara + Thymoglobuline D-1: Thymoglobuline D0: graft infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine, Busulfan, Thymoglobuline | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation | 12 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the "classical" criteria (clinical and biological) associated with outcome after allogeneic stem cell transplantation. To evaluate the impact of the modified Charlson comorbidity score (Sorror Score) on TRM and 1-year overall survival | 12 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad Mohty, MD, PhD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Marseille | 13273 | France | |||
| CHU de Nantes |
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| Nantes |
| 44093 |
| France |
| CHU de Bordeaux | Pessac | 33604 | France |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D002066 | Busulfan |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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