The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

February 8, 2024 updated by: Jun Shi, Institute of Hematology & Blood Diseases Hospital, China

A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic

This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

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

  • China
    • Henan
      • Zhoukou, Henan, China
        • Not yet recruiting
        • Zhoukou Central Hospital
        • Contact:
    • Shandong
      • Tai'an, Shandong, China
        • Not yet recruiting
        • The Second Affilated Hospital of Shandong First Medical University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China

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

6 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ECOG ≤ 3
  • Age from 6 to 70.
  • Diagnosed with WAIHA or MAIHA.
  • Meets the criteria of relapsed / refractory AIHA.
  • Meets the criteria of DAT-negative AIHA without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab.
  • Signed informed consent.
  • Organs in good function.

Exclusion Criteria:

  • Nursing woman
  • Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, etc.
  • Diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria.
  • Secondary AIHA caused by drugs or infection.
  • Received rituximab in 8 weeks before enrollment.
  • Previously received treatment with BTK inhibitor.
  • Previously received organ or stem cell transplantation.
  • Have a history of thrombosis or organ infarction.
  • Diagnosed with an active stage of connective tissue disease.
  • Have a history of lymphoproliferative tumors or any other malignant tumors.
  • Have other inherited or acquired hemolytic diseases.
  • Received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the Ibrutinib treatment.
  • Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment or during the Ibrutinib treatment.
  • Have a history of mental illness.
  • Inability to understand or to follow study procedures.

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: iBRIAN
Drug: Ibrutinib
Each recruited subject will accept Ibrutinib treatment.
Other Names:
  • BTK inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: within 12 weeks
within 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and severe adverse events
Time Frame: within 48 weeks
within 48 weeks
Relapse free survival rate
Time Frame: within 48 weeks
within 48 weeks

Collaborators and Investigators

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHBDH-IIT2020004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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