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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Active, not recruiting

Phase 2

Conditions

Refractory/Relapsed Autoimmune Hemolytic Anemia

Treatments

Drug: Ibrutinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04398459

IIT2020005

Details and patient eligibility

About

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

Enrollment

18 estimated patients

Sex

All

Ages

6 to 70 years old

Volunteers

No Healthy Volunteers

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.