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

NCT04398459 | Active Not Recruiting Phase 2

• 1 other identifier: IIT2020005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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

Keywords

Ibrutinib; BTK Inhibitor; autoimmune hemolytic anemia; AIHA

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  within 12 weeks

Secondary Outcomes (2)

• Incidence of adverse events and severe adverse events

  within 48 weeks

• Relapse free survival rate

  within 48 weeks

Study Arms (1)

iBRIAN

EXPERIMENTAL

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

Each recruited subject will accept Ibrutinib treatment.

Also known as: BTK inhibitor

iBRIAN

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (3)

Zhoukou Central Hospital

Zhoukou, Henan, China

Location

The Second Affilated Hospital of Shandong First Medical University

Tai’an, Shandong, China

Location

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Location

Related 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.

  PMID: 32536139 BACKGROUND

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

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: Director, Regenerative Medicine Clinic Center

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: May 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)