to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia
A sufficient explanation of the study should be provided to outpatients or inpatients who meet the research subject selection criteria. Then, it is conducted for those who have given their voluntary consent to participate in the study. Those enrolled in the study conduct according to the criteria specified in the protocol. In this clinical trial, 3 weeks is defined as 1 cycle. A total of 3 cycles will be performed, and follow-up will be conducted for 12 months. The study subjects will receive the test drug on an outpatient basis. At each outpatient visit, vital signs, medical history, physical examination, ECOG evaluation and blood tests are performed, and adverse reactions are checked. Bone marrow blood test is performed as an option at the discretion of the investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Bortezomib is administered at 1.3mg/m2 iv or sc on each Cycly Day1, Days4, and Days8. Bortezomib is administered every 3 weeks for a total of 3 cycles. Thereafter, follow-up is scheduled for 12 months.
Seoul National University Bundang Hospital
Guri-si, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSMG-SNU Boramae Medical Center
Seoul, South Korea
RECRUITINGConfirmation of efficacy of bortezomib in patients with relapsed/refractory immune thrombocytopenia requiring treatment
platelet \>30 x 109/L and at least twofold increase from baseline; complete \>100 x 109/L, partial 30-100 x 109/L, Platelet response rate at week 9.
Time frame: at week 9.
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Seoul National University Hospital
Seoul, South Korea
NOT_YET_RECRUITING