Back to resultsA Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
Primary Purpose
Immune Thrombocytopenia, Bruton's Tyrosine Kinase
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Orelabrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Orelabrutinib
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria for primary immune thrombocytopenia
- To show a platelet count < 30 * 10^9/L, or with bleeding manifestations, or both
- Willing and able to sign written informed consent
- Meet the diagnostic criteria of refractory ITP according to Chinese guidelines
Exclusion Criteria:
- Secondary thrombocytopenia
- severe immune-deficiency or history of primary immunodeficiency
- active or previous malignancy
- HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess)
- pregnancy or lactation
- diabetes
- hypertension
- cardiovascular diseases
- severe liver or kidney function impairment
- psychosis
- osteoporosis
- inflammatory bowel disease or gastric disease
- arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment
- an organ or haematopoietic stem-cell transplantation
- neutrophil count of less than 1500 cells per mm³; glycosylated haemoglobin less than 8%; partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN)
- clinical electrocardiogram changes
- neoplastic disease within the past 5 years
- corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
- substance misuse within the previous 12 months; and those who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Orelabrutinib
Arm Description
Orelabrutinib 50mg po qd
Outcomes
Primary Outcome Measures
Initial overall response to Orelabrutinib
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
Sustained overall response to Orelabrutinib
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
Secondary Outcome Measures
Time to response
Time from treatment initiation to achieve a complete response or a partial response
Duration of response
Time from achievement of a complete response or a partial response to the loss of response (platelet count <30×10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).
Therapy associated adverse events
Potential adverse events: leukopenia (report in number * 10^9/L, time of occurrence and duration); nausea and diarrhea (report in frequency); infection (report pathogens and infectious diseases).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05020288
Brief Title
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
Official Title
A Prospective, Open-label, Multicenter，Single-armed Study of Orelabrutinib in the Treatment of Refractory Primary Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
BTK participates in a variety of signal transduction of innate and adaptive immunity, and has an important role in cell proliferation, differentiation and apoptosis. The impact of BTK inhibitors on hematological malignancies and autoimmune diseases has been well studied. This project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of the selective BTK inhibitor Orelabrutinib in the management of refractory ITP.
Detailed Description
The investigators are undertaking a prospective, open-lable, multicentre trial of 40 refractory ITP adult patients in China. Eligible participants will receive Orelabrutinib in 50 mg po. qd, every 4 weeks for one cycle and it will be given 3 cycles. For non-responders who were well tolerated at 12 weeks of follow-up, the treatment could be extended to 6 cycles. The treatment will be discontinued after 6 months without blood index reaction. In order to report the efficacy and safety of Orelabrutinib in the management of refractory ITP, platelet count, bleeding and other symptoms will be evaluated before and after treatments. Adverse events are also recorded throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia, Bruton's Tyrosine Kinase
Keywords
Orelabrutinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orelabrutinib
Arm Type
Experimental
Arm Description
Orelabrutinib 50mg po qd
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib
Other Intervention Name(s)
ICP-022
Intervention Description
Orelabrutinib 50mg po qd, every four weeks for one cycle. It will be given three cycles.
Primary Outcome Measure Information:
Title
Initial overall response to Orelabrutinib
Description
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
Time Frame
14 days after the first dose of Orelabrutinib
Title
Sustained overall response to Orelabrutinib
Description
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
Time Frame
A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response
Secondary Outcome Measure Information:
Title
Time to response
Description
Time from treatment initiation to achieve a complete response or a partial response
Time Frame
An average of 6 months
Title
Duration of response
Description
Time from achievement of a complete response or a partial response to the loss of response (platelet count <30×10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).
Time Frame
through study completion, an average of 1 year
Title
Therapy associated adverse events
Description
Potential adverse events: leukopenia (report in number * 10^9/L, time of occurrence and duration); nausea and diarrhea (report in frequency); infection (report pathogens and infectious diseases).
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the diagnostic criteria for primary immune thrombocytopenia
To show a platelet count < 30 * 10^9/L, or with bleeding manifestations, or both
Willing and able to sign written informed consent
Meet the diagnostic criteria of refractory ITP according to Chinese guidelines
Exclusion Criteria:
Secondary thrombocytopenia
severe immune-deficiency or history of primary immunodeficiency
active or previous malignancy
HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess)
pregnancy or lactation
diabetes
hypertension
cardiovascular diseases
severe liver or kidney function impairment
psychosis
osteoporosis
inflammatory bowel disease or gastric disease
arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment
an organ or haematopoietic stem-cell transplantation
neutrophil count of less than 1500 cells per mm³; glycosylated haemoglobin less than 8%; partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN)
clinical electrocardiogram changes
neoplastic disease within the past 5 years
corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
substance misuse within the previous 12 months; and those who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Hou, MD,PhD
Phone
0531-82169879
Email
houming@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou, MD,PhD
Organizational Affiliation
Shandong University Qilu Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
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