The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia

NCT05599880 | Recruiting Phase 2 DMC

• 1 other identifier: BORRELIA
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia

Conditions

Relapsed/Refractory Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 9.

Study Arms (1)

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.

Drug: Bortezomib

Interventions

Bortezomib DRUG

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.

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

Seoul National University Bundang Hospital

Guri-si, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dong-Yeop Shin, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Dong-Yeop Shin, MD, PhD

CONTACT

02-2072-7209; stephano.dyshin@gmail.com

hye-young Jung

CONTACT

82-2-6072-5207; gracethanks@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: hematology oncology Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: July 7, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

KR (4)