Myelodysplastic Syndromes
Conditions
Keywords
Myelodysplastic syndromes, IPSS Int-2 and High risk, Bortezomib, Low dose Cytarabine, Bone Marrow diseases
Brief summary
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.
Detailed description
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting Cycle 1 : * Cytarabine 10 mg /m2/day subcutaneous injection for 14 days * Bortézomib 1,5mg/m2 days 1,4,8,11 Cycles 2, 3, 4 : * Cytarabine 20 mg /m2/j subcutaneous injections for 14 days * Bortézomib 1,5mg/m2 days 1,4,8,11 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
Interventions
DRUGBortezomib
Sponsors
Johnson & Johnson
Groupe Francophone des Myelodysplasies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Essai ouvert multicentrique de phase I-II
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* MDS with IPSS scores Int-2 or High * Life expectancy greater than 6 months * No other available treatment options
Exclusion criteria
* MDS with IPSS scores Low or Int-1 * \> 30% bone marrow blasts * clinical neuropathy of greater than grade 2 * ECOG Score 3 or 4 * Creatinine clearance of \< 30 ml/min * LMMC * Pregnant patients or lactating mothers * Patients having received intensive chemotherapy in the 3 months prior to inclusion * Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | — | — |
| Partial Response | — | — |
| Efficacy and safety evaluation | 18 mois | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Hematological Improvement | — |
Countries
France
Outcome results
None listed