Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes

Phase 2CompletedNCT00411905

Groupe Francophone des Myelodysplasies45 enrolled

Overview

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 : * 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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndromes

Interventions

BortezomibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

CHU Angers

Angers, France

Hopital Avicenne

Bobigny, France

Institut Bergonie

Bordeaux, France

Outcomes

Primary Outcomes

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

Time frame: 18 mois

Secondary Outcomes

Hematological Improvement

Data from ClinicalTrials.gov

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