Cancer drug could help patients with low platelet disorder
NCT ID NCT05599880
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests the drug bortezomib in 29 adults with relapsed or refractory immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, raising bleeding risk. Participants receive bortezomib injections over three weeks for three cycles, then are followed for a year. The goal is to see if the drug can safely raise platelet counts to safer levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bortezomib
- What this could lead to
- If successful, bortezomib could offer a new treatment option for people with immune thrombocytopenia that hasn't responded to other therapies.
- What could go wrong
- This is a small, early-phase trial with only 29 participants. It may not work for everyone, and bortezomib can cause side effects like nerve damage and low blood cell counts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men and women 19 years of age and older 2. Patients diagnosed with immune thrombocytopenia (primary or secondary) 3. (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. 4. platelets \<30 x 109/L 5. Patients in need of clinical treatment. 6. 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. 7. Patients who have been relapsed or refractory after receiving at least 2 treatments with a mechanism other than corticosteroids. 8. 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 9. Female patients of childbearing potential should have a negative urine or serum pregnancy test within 28 days before starting administration of the test drug. 10. Patients who voluntarily or legal guardians have given written consent to participate in this clinical trial. Exclusion Criteria: 1. pregnant, lactating women 2. Patients allergic to bortezomib. 3. Patients with Grade 2 or higher peripheral neuropathy requiring drug treatment. 4. Patients with severe or uncontrolled active infection. 5. Patients with significant immunoglobulin degradation in the immunoglobulin profile. 6. 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.) 7. Patients currently undergoing chemotherapy. 8. 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.) 9. 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. 10. Patients currently participating in other clinical trials. 11. Patients who are not considered suitable for participation in clinical trials in the opinion of the researcher. 12. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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SMG-SNU Boramae Medical Center
RECRUITINGSeoul, 07061, South Korea
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Seoul National University Bundang Hospital
RECRUITINGGuri-si, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Seoul National University Hospital
NOT_YET_RECRUITINGSeoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World data may reveal which ITP treatments work best
- A diet tweak may boost platelets in a bleeding disorder
- Can a new drug calm the immune System's attack on blood cells?
- Double attack on blood disorder: could two drugs beat one for stubborn ITP?
- Could a cholesterol drug and antioxidant help treat a rare bleeding disorder?
- New hope for lupus patients with dangerous low platelet counts