Relapsed/Refractory Immune ThrombocytopeniaPhase 2NCT05599880
The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia
A Phase 2 study testing Bortezomib in people with Relapsed/Refractory Immune Thrombocytopenia, run by Seoul National University Hospital at 4 sites in South Korea.
Trial summary
to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Relapsed/Refractory Immune Thrombocytopenia
- What is being tested?
- Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 7 Jul 2023to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 19 years of age and older
- Patients diagnosed with immune thrombocytopenia (primary or secondary)
- (Patients with at least one of B, C, or D meeting A below.) A.A person who has been confirmed not to be due to a cause of decreased platelet production in the bone marrow in the results of bone marrow examination within the past 5 years. (Bone marrow examination is required if there is no bone marrow examination result within the last 5 years.) B.After being diagnosed with ITP, there has been a case of complete platelet response with plt >100k in immunoglobulin therapy.
- C.Patients suspected of having primary immune thrombocytopenia with proven anti-platelet antibody., D.Helicobacter IgG, antinuclear antibody (ANA), anticardiolipin antibody (ACA), nonspecific inhibitor (NSI), etc. have been proven, and secondary immune thrombocytopenia caused by autoimmune disease is suspected.
- platelets <30 x 109/L
- Patients in need of clinical treatment.
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- Patients who have relapsed or refractory after receiving treatment with corticosteroids (prednisolone cumulative dose 5.6mg/kg (0.8mg/kg 1 week) or more or dexamethasone cumulative dose 80mg (20mg 4 days) or more)., However, there are exceptions when corticosteroids are contraindicated.
- Patients who have been relapsed or refractory after receiving at least 2 treatments with a mechanism other than corticosteroids.
- Patients who underwent two different treatments from among the treatment methods below.
- Splenectomy
- eltrombopag or romiplostim
- Rituximab treatment
- Azathioprine
- cyclosporine or mycophenolate mofetil(MMF)
- vincristine or cyclophosphamide
- danazol
- dapsone
- Alemtuzumab
- Female patients of childbearing potential should have a negative urine or serum pregnancy test within 28 days before starting administration of the test drug.
- Patients who voluntarily or legal guardians have given written consent to participate in this clinical trial.
Who cannot join
- pregnant, lactating women
- Patients allergic to bortezomib.
- Patients with Grade 2 or higher peripheral neuropathy requiring drug treatment.
- Patients with severe or uncontrolled active infection.
- Patients with significant immunoglobulin degradation in the immunoglobulin profile.
- HBV, HCV carrier or HIV patient. (However, if the patient is being stably maintained with antiviral treatment, and the expert opinion determines that it is possible to participate in the clinical trial along with antiviral treatment and prevention, participation is possible.)
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- Patients currently undergoing chemotherapy.
- Patients whose bone marrow did not recover after cancer treatment, or whose cause other than immune destruction was confirmed by bone marrow examination, such as thrombocytopenia due to intramedullary abnormalities. However, if the presence of anti-platelet antibodies is proven and thrombocytopenia due to immune destruction is strongly suspected clinically, registration is possible even if there are other causes of thrombocytopenia.)
- Patients who may become pregnant. However, women of childbearing age(If postmenopausal women are not of childbearing age, they must have been menstruating for at least 12 months.) who have not undergone sterilization can participate in the clinical trial only if the pregnancy test is negative. And, effective contraception must be maintained throughout the entire trial period.
- Patients currently participating in other clinical trials.
- Patients who are not considered suitable for participation in clinical trials in the opinion of the researcher.
- Patients with inadequate organ function.
- total bilirubin > 3 x ULN
- creatinine > 1.5 x ULN
- liver function test AST(SGOT) \& ALT(SGPT) > 3 x ULN
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Guri-si
Ji Yoon Lee
- Recruiting
Seoul National University Hospital
Seoul, 03080
Dong-Yeop Shin, M.D.
- Recruiting
SMG-SNU Boramae Medical Center
Seoul, 07061
Songyi Park, +82-2-870-2177, brmhrc@brmh.org
- Not yet recruiting
Seoul National University Hospital
Seoul
Dong-Yeop Shin, MD, PhD, 02-2072-7209, stephano.dyshin@gmail.com
Dong-Yeop Shin, MD, PhD
About this study
Official title: A Phase 2 Study to Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia
to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia
Read the detailed description
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.
- Being tested
- Bortezomib
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation 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.
Measured: at week 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start7 Jul 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Yeop Shin, Seoul National University Hospital
- Investigators
- Dong-Yeop Shin, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599880
- Sponsor's protocol ID
- BORRELIA
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05599880
- Acronym / sponsor ID
- BORRELIA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: BortezomibBortezomib 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Men and women 19 years of age and older
- Patients diagnosed with immune thrombocytopenia (primary or secondary)
- (Patients with at least one of B, C, or D meeting A below.) A.A person who has been confirmed not to be due to a cause of decreased platelet production in the bone marrow in the results of bone marrow examination within the past 5 years. (Bone marrow examination is required if there is no bone marrow examination result within the last 5 years.) B.After being diagnosed with ITP, there has been a case of complete platelet response with plt >100k in immunoglobulin therapy.
- C.Patients suspected of having primary immune thrombocytopenia with proven anti-platelet antibody., D.Helicobacter IgG, antinuclear antibody (ANA), anticardiolipin antibody (ACA), nonspecific inhibitor (NSI), etc. have been proven, and secondary immune thrombocytopenia caused by autoimmune disease is suspected.
- platelets <30 x 109/L
Key exclusion criteria (15 listed)
- pregnant, lactating women
- Patients allergic to bortezomib.
- Patients with Grade 2 or higher peripheral neuropathy requiring drug treatment.
- Patients with severe or uncontrolled active infection.
- Patients with significant immunoglobulin degradation in the immunoglobulin profile.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibBortezomib 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. | Drug | Treatment |
Primary outcome
Confirmation of efficacy of bortezomib in patients with relapsed/refractory immune thrombocytopenia requiring treatment
Time frame: at week 9.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong-Yeop Shin, MD, PhD study chair
Seoul National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib in people with Relapsed/Refractory Immune Thrombocytopenia, run by Seoul National University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Yeop Shin, MD, PhD (02-2072-7209, stephano.dyshin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation of efficacy of bortezomib in patients with relapsed/refractory immune thrombocytopenia requiring treatment (time frame: at week 9.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.