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

Primary Purpose

Immune Thrombocytopenia

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Zanubrutinib

Dexamethasone

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring BTK inhibitor, High-dose Dexamethasone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed newly-diagnosed, treatment-naive ITP;
Platelet counts <30×10^9/L ;
Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
Willing and able to sign written informed consent.

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
Current HIV infection or hepatitis B virus or hepatitis C virus infections;
Active infection;
Maligancy;
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);
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;
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zanubrutinib and HD-DXM

HD-DXM

Arm Description

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10) and Zanubrutinib 80mg qd po, 6 consecutive weeks

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Initial complete response

Initial complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.

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.

Number of patients with bleeding

Number of patients with bleeding complication ( WHO bleeding score).

Number of patients with adverse events

Time to response (TTR)

The time from starting treatment to time of achievement of CR or R

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)

Durable response

Platelet count ≥30 X 10^9/L and at least doubling of the baseline count at 6 mo

Early response

Platelet count ≥30 X 10^9/L and at least doubling baseline at 1 wk

Remission

Platelet count >100 X 10^9/L at 12 month

Full Information

NCT ID

NCT05369364

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

NCT05369364

Brief Title

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

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

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

December 30, 2025 (Anticipated)

Study Completion Date

June 1, 2026 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia

Keywords

BTK inhibitor, High-dose Dexamethasone

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 HD-DXM

Arm Type

Experimental

Arm Description

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10) and Zanubrutinib 80mg qd po, 6 consecutive weeks

Arm Title

HD-DXM

Arm Type

Active Comparator

Arm Description

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10)

Intervention Type

Drug

Intervention Name(s)

Zanubrutinib

Other Intervention Name(s)

BTK inihibitor

Intervention Description

Zanubrutinib 80mg qd po, 6 consecutive weeks

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

HD-DXM

Intervention Description

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)

Primary Outcome Measure Information:

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 months

Secondary Outcome Measure Information:

Title

Initial complete response

Description

Initial complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.

Time Frame

1 month

Title

Initial response

Description

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.

Time Frame

1 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

Time to response (TTR)

Description

The time from starting treatment to time of achievement of CR or R

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 month

Title

Durable response

Description

Platelet count ≥30 X 10^9/L and at least doubling of the baseline count at 6 mo

Time Frame

6 months

Title

Early response

Description

Platelet count ≥30 X 10^9/L and at least doubling baseline at 1 wk

Time Frame

1 week

Title

Remission

Description

Platelet count >100 X 10^9/L at 12 month

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

Eligibility Criteria

Inclusion Criteria: Confirmed newly-diagnosed, treatment-naive ITP; Platelet counts <30×10^9/L ; Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above); Willing and able to sign written informed consent. Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit; Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ; Current HIV infection or hepatitis B virus or hepatitis C virus infections; Active infection; Maligancy; 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); 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaohui Zhang, MD

Phone

+8613522338836

zhangxh100@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qiusha Huang, MD

Phone

+8613051816058

huangfuqs@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaohui Zhang, md

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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