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

NCT ID: NCT04398459

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2025-06-30

Brief 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.

Conditions

Refractory/Relapsed Autoimmune Hemolytic Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iBRIAN

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: DRUG

Each recruited subject will accept Ibrutinib treatment.

Interventions

Ibrutinib

Each recruited subject will accept Ibrutinib treatment.

Intervention Type: DRUG

Other Intervention Names

BTK inhibitor

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Jun Shi

Director, Regenerative Medicine Clinic Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhoukou Central Hospital

Zhoukou, Henan, China

The Second Affilated Hospital of Shandong First Medical University

Tai’an, Shandong, China

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 32536139 (View on PubMed)

Other Identifiers

IIT2020005

Identifier Type: -

Identifier Source: org_study_id