The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

The Combination of Oral Zanubrutinib and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05369364
• Other study ID #: HDDXM-Zan-ITP
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: June 1, 2026

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 high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Description:

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with ITP in China. Patients were randomized to Zanubrutinib + high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Confirmed newly-diagnosed, treatment-naive ITP;

2. Platelet counts <30×10^9/L ;

3. Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;

2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;

3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;

4. Active infection;

5. Maligancy;

6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);

7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy;

8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Zanubrutinib
Zanubrutinib 80mg qd po, 6 consecutive weeks
• Dexamethasone
Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)

Locations

Country	Name	City	State
n/a

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 months
Secondary	Initial complete response	Initial complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.	1 month
Secondary	Initial response	Initial response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.	1 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	Time to response (TTR)	The time from starting treatment to time of achievement of CR or R	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 month
Secondary	Durable response	Platelet count =30 X 10^9/L and at least doubling of the baseline count at 6 mo	6 months
Secondary	Early response	Platelet count =30 X 10^9/L and at least doubling baseline at 1 wk	1 week
Secondary	Remission	Platelet count >100 X 10^9/L at 12 month	12 months