Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05369377
• Other study ID #: Zan-Eltro-ITP
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2022
• Source: Peking University People's Hospital
• Contact: Xiaohui Zhang, MD
• Phone: +8613522338836
• Email: zhangxh100[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;

2. 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:

1. Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)

2. congestive heart failure

3. severe arrhythmia

4. nursing or pregnant women

5. aspartate aminotransferase and alanine transaminase levels = 3× the upper limit of the normal threshold criteria

6. creatinine or serum bilirubin levels each 1•5 times or more than the normal range

7. active or previous malignancy

8. Unable to do blood routine test for the sake of time, distance, economic issues or other reasons

9. History of clotting disorder

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Zanubrutinib
Zanubrutinib 80mg po qd 6 weeks
• Eltrombopag
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.

Locations

Country	Name	City	State
China	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Aerospace General Hospital, Beijing Hospital, Beijing Tongren Hospital, Qilu Hospital of Shandong University, The Sixth Medical Center of PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks
Secondary	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	6 weeks
Secondary	Complete response (CR)	Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding	6 weeks
Secondary	Time to response	The time from starting treatment to time of achievement of Response	6 weeks
Secondary	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	12 month
Secondary	Number of patients with bleeding	Number of patients with bleeding complication ( WHO bleeding score)	12 months
Secondary	Number of patients with adverse events	Number of patients with adverse events	12 months
Secondary	Duration of response (DOR)	Duration of response at 12-month follow up	12 months
Secondary	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)	12 months