Back to resultsThe Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
Primary Purpose
Refractory/Relapsed Autoimmune Hemolytic Anemia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ibrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Refractory/Relapsed Autoimmune Hemolytic Anemia focused on measuring Ibrutinib, BTK Inhibitor, autoimmune hemolytic anemia, AIHA
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.
Sites / Locations
- Zhoukou Central Hospital
- The Second Affilated Hospital of Shandong First Medical University
- Regenerative Medicine CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iBRIAN
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Incidence of adverse events and severe adverse events
Relapse free survival rate
Full Information
NCT ID
NCT04398459
First Posted
May 18, 2020
Last Updated
August 15, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04398459
Brief Title
The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
Official Title
A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory/Relapsed Autoimmune Hemolytic Anemia
Keywords
Ibrutinib, BTK Inhibitor, autoimmune hemolytic anemia, AIHA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iBRIAN
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
BTK inhibitor
Intervention Description
Each recruited subject will accept Ibrutinib treatment.
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
within 12 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events and severe adverse events
Time Frame
within 48 weeks
Title
Relapse free survival rate
Time Frame
within 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Shi, PhD
Phone
(86)2223900913
Email
shijun@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyu Zhao, MPH
Phone
(86)13752253515
Email
zhaojingyu@ihcams.ac.cn
Facility Information:
Facility Name
Zhoukou Central Hospital
City
Zhoukou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Liang, PhD
Phone
15703815972
Email
lqw141230@163.com
Facility Name
The Second Affilated Hospital of Shandong First Medical University
City
Tai'an
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang
Phone
18505386878
Email
tyfyzhh@163.com
Facility Name
Regenerative Medicine Center
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Shi, PhD
Phone
(86)2223900913
Email
shijun@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Jingyu Zhao, MPH
Phone
(86)13752253515
Email
zhaojingyu@ihcams.ac.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32536139
Citation
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.
Results Reference
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The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
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