NCT07315373

Brief Summary

The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
39mo left

Started Dec 2025

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Dec 2025Jun 2029

First Submitted

Initial submission to the registry

December 18, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

December 18, 2025

Last Update Submit

December 18, 2025

Conditions

Immune Thrombocytopenia

Keywords

ITPzanubrutinib

Outcome Measures

Primary Outcomes (1)

  • 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 26-week follow-up.

    26 weeks

Secondary Outcomes (8)

  • Initial Response (R)

    day 14

  • Initial complete response (CR)

    day 14

  • Time to response

    6 month

  • Duration of response (DOR)

    26 weeks

  • Bleeding events

    26 weeks

  • +3 more secondary outcomes

Study Arms (3)

Zanubrutinib 80mg/d + Dexamethasone

EXPERIMENTAL

Participants in this arm will receive a combination therapy consisting of: Zanubrutinib: 80 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.

Drug: Zanubrutinib 80mg/dDrug: High dose dexamethasone

Zanubrutinib 160mg/d + Dexamethasone

EXPERIMENTAL

Participants in this arm will receive a combination therapy consisting of: Zanubrutinib: 160 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.

Drug: High dose dexamethasoneDrug: Zanubrutinib 160mg/d

Zanubrutinib 240mg/d + Dexamethasone

EXPERIMENTAL

Participants in this arm will receive a combination therapy consisting of: Zanubrutinib: 240 mg taken orally once daily for 26 weeks. Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.

Drug: High dose dexamethasoneDrug: Zanubrutinib 240mg/d

Interventions

Zanubrutinib 80mg/dDRUG

Zanubrutinib: 80 mg taken orally once daily for 26 weeks

Zanubrutinib 80mg/d + Dexamethasone
High dose dexamethasoneDRUG

Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.

Zanubrutinib 160mg/d + DexamethasoneZanubrutinib 240mg/d + DexamethasoneZanubrutinib 80mg/d + Dexamethasone
Zanubrutinib 160mg/dDRUG

Zanubrutinib: 160 mg taken orally once daily for 26 weeks

Zanubrutinib 160mg/d + Dexamethasone
Zanubrutinib 240mg/dDRUG

Zanubrutinib: 240 mg taken orally once daily for 26 weeks

Zanubrutinib 240mg/d + Dexamethasone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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;
  • Patients who are deemed unsuitable for the study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

zanubrutinibDexamethasone

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Xiaohui Zhang

    Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

8688324577zhangxh100@sina.com

Qiusha Huang, MD

CONTACT

8688324577huangfuqs@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Peking University Institute of Hematology

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start

December 25, 2025

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

January 2, 2026

Record last verified: 2025-12