Spots Global Cancer Trial Database for APG101 in Myelodysplastic Syndrome

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Trial Identification

Brief Title: APG101 in Myelodysplastic Syndrome

Official Title: APG101 in Transfusion-Dependent Patients With Low or Intermediate Risk Myelodysplastic Syndrome

Study ID: NCT01736436

Conditions

Myelodysplastic Syndrome

Interventions

Treatment with APG101

Bone marrow collection

Blood drawings

Study Description

Brief Summary: It has been shown in preclinical experiments with bone marrow from patients with myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients. APG101 might, therefore, be a valuable addition to current treatments of low- or intermediate MDS patients suffering from anaemia. Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic Scoring Scale (WPSS) can be included in this study. Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6 months follow up phase. Primary objective of the trial is safety and tolerability of APG101; secondary objectives are * Hematologic, cytologic and cytogenetic response rate using modified International Working Group (IWG) response criteria * Incidence and time to leukemic progression at 37 weeks * OS (Overall survival) at 37 weeks

Detailed Description: