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

Refractory/Relapsed Autoimmune Hemolytic Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398459
• Other study ID #: IHBDH-IIT2020004
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Jun Shi, PhD
• Phone: (86)2223900913
• Email: shijun[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Hemolysis
• Refractory/Relapsed Autoimmune Hemolytic Anemia

Intervention

Drug:
• Ibrutinib
Each recruited subject will accept Ibrutinib treatment.

Locations

Country	Name	City	State
China	The Second Affilated Hospital of Shandong First Medical University	Tai'an	Shandong
China	Regenerative Medicine Center	Tianjin	Tianjin
China	Zhoukou Central Hospital	Zhoukou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (1)

Fang LW, Pan H, Shi J. [Ibrutinib treatment for 2 cases of relapsed/refractory autoimmune hemolytic anemia: a pilot study]. Zhonghua Xue Ye Xue Za Zhi. 2020 May 14;41(5):412-416. doi: 10.3760/cma.j.issn.0253-2727.2020.05.009. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		within 12 weeks
Secondary	Incidence of adverse events and severe adverse events		within 48 weeks
Secondary	Relapse free survival rate		within 48 weeks