Actively Recruiting
The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia
Led by Seoul National University Hospital · Updated on 2026-02-02
29
Participants Needed
4
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia
CONDITIONS
Official Title
The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 19 years of age and older
- Diagnosed with immune thrombocytopenia (primary or secondary)
- Confirmed not to have decreased platelet production caused by bone marrow issues within the past 5 years (bone marrow exam required if none within 5 years)
- History of complete platelet response (>100k) after immunoglobulin therapy or presence of anti-platelet antibodies or suspected secondary immune thrombocytopenia due to autoimmune disease
- Platelet count less than 30 x 10^9/L
- In need of clinical treatment
- Relapsed or refractory after corticosteroid treatment (prednisolone or dexamethasone), unless corticosteroids are contraindicated
- Relapsed or refractory after at least 2 treatments besides corticosteroids
- Have undergone two different treatments from options such as splenectomy, thrombopoietin receptor agonists, rituximab, immunosuppressants, chemotherapy agents, or other listed therapies
- Female patients of childbearing potential must have a negative pregnancy test within 28 days before treatment
- Provided voluntary written consent to participate
You will not qualify if you...
- Pregnant or lactating women
- Allergy to bortezomib
- Peripheral neuropathy Grade 2 or higher requiring treatment
- Severe or uncontrolled active infection
- Significant immunoglobulin degradation
- Carrier of HBV, HCV, or HIV unless stably maintained with antiviral treatment and approved by expert opinion
- Currently undergoing chemotherapy
- Bone marrow not recovered after cancer treatment or thrombocytopenia caused by marrow abnormalities unless immune destruction is proven
- Women who may become pregnant without effective contraception and negative pregnancy test
- Currently participating in other clinical trials
- Deemed unsuitable by researcher
- Inadequate organ function defined by elevated bilirubin, creatinine, or liver enzymes beyond specified limits
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Seoul National University Bundang Hospital
Guri-si, South Korea
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
3
SMG-SNU Boramae Medical Center
Seoul, South Korea, 07061
Actively Recruiting
4
Seoul National University Hospital
Seoul, South Korea
Not Yet Recruiting
Research Team
D
Dong-Yeop Shin, MD, PhD
CONTACT
H
hye-young Jung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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