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Randomized phase II trial to evaluate the effectiveness of azacitidine for low risk MDS.

Phase 2
Conditions
lower risk myelodysplastic syndrome
Registration Number
JPRN-UMIN000010855
Lead Sponsor
ational Research Group on Idiopathic Bone Marrow Failure Syndromes
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

1)Cases with scheduled hematopoietic stem cell transplantation. We do not exclude patients who are judged as transplant candidate after entry of this study because of change of medical conditions. 2)Cases who received hematopoietic stem cell transplantation. 3)Cases who had already been enrolled into other clinical trials for MDS. 4)Cases with pregnancy, possibility of pregnancy, in breast-feeding, or with plant to bear a child 5)Cases with hypersensitivity to azacitidine. 6)Cases with other cancers than MDS that is invasive within 5 years. 7)Cases with complicating diseases that are severe or uncontrolled. 8)Cases with psychiatric diseases or psychiatric symptoms that preclude adequate entry to the study. 9)Cases with cognitive disorders. 10)Patients who are receiving successful treatment with other modalities, or who are expected to achieve better response with other treatments (such as with 5q- syndrome). 11)Cases that are considered to be inadequate to enroll this study by the attending physicians.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
This study has two primary endpoints for induction phase and maintenance phase, respectively. Induction phase: the ratio of cases in which hematological improvement is achieved with 6 course of azacitidine therapy. Maintenance phase: the ratio of patients who maintained hematological effectiveness achieved in the induction phase after one year with or without azacitidine maintenance therapy.
Secondary Outcome Measures
NameTimeMethod
Induction phase: Achievement ratio of hematological improvement for each of hematological series. Cytogenetic response ratio. Transfusion dependence ratio at the end of induction phase. Sustainability of induction therapy. Incidence of Grade 3 side effects or higher. Incidence of infection that need intravenous antibiotics. Overall survival ratio. Progression free survival ratio to AML. Maintenance phase: the ratio of patients who maintained hematological effectiveness after two years. Ratio of AML development. Ratio of patients who received hematopoietic stem cell transplantation. Incidence of Grade 3 side effects or higher. Incidence of infection that need intravenous antibiotics. Overall survival ratio. Progression free survival ratio to AML.
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