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

October 17, 2023 updated by: Dong-Yeop Shin, Seoul National University Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Guri-si, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Ji Yoon Lee
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Dong-Yeop Shin, M.D.
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Yeop Shin, MD, PhD
        • Sub-Investigator:
          • Sung-Soo Yoon, MD, PhD
        • Sub-Investigator:
          • Jamin Byun, MD, PhD
        • Sub-Investigator:
          • Youngil Koh, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at week 9.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Dong-Yeop Shin, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BORRELIA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsed/Refractory Immune Thrombocytopenia

Clinical Trials on Bortezomib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe