Back to resultsZanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
Primary Purpose
Immune Thrombocytopenia
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zanubrutinib
Eltrombopag
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring BTK inhibitor, Thrombopoietin-receptor agonist
Eligibility Criteria
Inclusion Criteria:
- Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
- Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count
2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. Willing and able to sign written informed consent
Exclusion Criteria:
- Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
- congestive heart failure
- severe arrhythmia
- nursing or pregnant women
- aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
- creatinine or serum bilirubin levels each 1•5 times or more than the normal range
- active or previous malignancy
- Unable to do blood routine test for the sake of time, distance, economic issues or other reasons
- History of clotting disorder
Sites / Locations
- Peking University Insititute of Hematology, Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Zanubrutinib and eltrombopag
Eltrombopag monotherapy
Arm Description
Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks.
Eltrombopag is given as 50 mg qd for up to 6 weeks.
Outcomes
Primary Outcome Measures
Treatment response
The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment
Secondary Outcome Measures
Overall response
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication after 6 weeks of treatment
Complete response (CR)
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding
Time to response
The time from starting treatment to time of achievement of Response
Sustained response
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 12-month follow-up
Number of patients with bleeding
Number of patients with bleeding complication ( WHO bleeding score)
Number of patients with adverse events
Number of patients with adverse events
Duration of response (DOR)
Duration of response at 12-month follow up
Loss of response
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Full Information
NCT ID
NCT05369377
First Posted
May 6, 2022
Last Updated
May 6, 2022
Sponsor
Peking University People's Hospital
Collaborators
Beijing Hospital, Navy General Hospital, Beijing, Beijing Aerospace General Hospital, Qilu Hospital of Shandong University, Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05369377
Brief Title
Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
Official Title
Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Beijing Hospital, Navy General Hospital, Beijing, Beijing Aerospace General Hospital, Qilu Hospital of Shandong University, Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).
Detailed Description
The investigators are undertaking a prospective trial of patients with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Eltrombopag is given with 50 mg once daily for up to 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. This study assessed the efficacy and safety of eltrombopag plus zanubrutinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
BTK inhibitor, Thrombopoietin-receptor agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zanubrutinib and eltrombopag
Arm Type
Experimental
Arm Description
Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks.
Arm Title
Eltrombopag monotherapy
Arm Type
Active Comparator
Arm Description
Eltrombopag is given as 50 mg qd for up to 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
BTK inihibitor
Intervention Description
Zanubrutinib 80mg po qd 6 weeks
Intervention Type
Drug
Intervention Name(s)
Eltrombopag
Intervention Description
eltrombopag 50 mg qd for up to 6 weeks. The eltrombopag dose could be increased from 50 mg to 75 mg after 3 weeks in patients whose platelet counts were less than 50 000 per μL. Treatment was discontinued in patients who attained a platelet count greater than 200 000 per μL.
Primary Outcome Measure Information:
Title
Treatment response
Description
The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Overall response
Description
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication after 6 weeks of treatment
Time Frame
6 weeks
Title
Complete response (CR)
Description
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding
Time Frame
6 weeks
Title
Time to response
Description
The time from starting treatment to time of achievement of Response
Time Frame
6 weeks
Title
Sustained response
Description
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 12-month follow-up
Time Frame
12 month
Title
Number of patients with bleeding
Description
Number of patients with bleeding complication ( WHO bleeding score)
Time Frame
12 months
Title
Number of patients with adverse events
Description
Number of patients with adverse events
Time Frame
12 months
Title
Duration of response (DOR)
Description
Duration of response at 12-month follow up
Time Frame
12 months
Title
Loss of response
Description
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Time Frame
12 months
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:
Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count
2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. Willing and able to sign written informed consent
Exclusion Criteria:
Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
congestive heart failure
severe arrhythmia
nursing or pregnant women
aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
creatinine or serum bilirubin levels each 1•5 times or more than the normal range
active or previous malignancy
Unable to do blood routine test for the sake of time, distance, economic issues or other reasons
History of clotting disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Zhang, MD
Phone
+8613522338836
Email
zhangxh100@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiusha Huang, MD
Phone
+8613051816058
Email
huangfuqs@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui Zhang, md
Organizational Affiliation
Peking University People's Hospital, Peking University Insititute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Insititute of Hematology, Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
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