Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting
Cycle 1 :
Cycles 2, 3, 4 :
Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles
Responding patients may continue the treatment for 2 further cycles
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | ||
| Partial Response | ||
| Efficacy and safety evaluation | A total of 138 cycles were administered. The median number of cycles administered was 3·2 (range 0·5-8). Thirty-six patients (84%) received at least two cycles and 17 (40%) received the planned four cycles, six responding patients received 1-4 additional cycles. Treatment was dis- continued in the responding patients at progression to AML or for toxicity. The most common treatment-related adverse events were related to myelosuppression . Neutropenia (Grade 4) and thrombocytopenia (Grade 4) were seen during treatment in 51% and 46% of the patients, respectively. Three of the patients with pre-treatment Grade 0-2 neutropenia and thrombocytopenia developed Grade 3-4 toxicity complicated by infection and bleeding. Grade 3-4 neutropenia was responsible for infection in six patients. Grade 3-4 | 18 mois |
| Measure | Description | Time Frame |
|---|---|---|
| Hematological Improvement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francois DREYFUS, MD PhD | Groupe francaise des Myelodysplasies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 43033 | France | |||
| Hopital Avicenne |
Not provided
Essai ouvert multicentrique de phase I-II
Not provided
Not provided
Not provided
Not provided
| Bobigny |
| 93009 |
| France |
| Institut Bergonie | Bordeaux | 33076 | France |
| CHU de Caen | Caen | 14033 | France |
| CHU Dijon | Dijon | 21000 | France |
| CHU Albert Michallon | Grenoble | 38043 | France |
| CHU de Limoges | Limoges | 87046 | France |
| Hopital Paoli Calmette | Marseille | 13273 | France |
| CHU Archet | Nice | 06202 | France |
| Hopital Cochin | Paris | 75014 | France |
| Centre Hospitalier Joffre | Perpignan | 66046 | France |
| Centre Henry Becquerel | Rouen | 76038 | France |
| Centre Hospitalier Universitaire de STRASBOURG | Strasbourg | 67098 | France |
| CHU Purpan | Toulouse | 31059 | France |
| CHU Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided