NCT05369364

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).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
1mo left

Started Jun 2022

Typical duration for phase_2

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 Progress99%
Jun 2022Jun 2026

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

3.6 years

First QC Date

May 6, 2022

Last Update Submit

May 6, 2022

Conditions

Immune Thrombocytopenia

Keywords

BTK inhibitorHigh-dose Dexamethasone

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 12-month follow-up

    12 months

Secondary Outcomes (10)

  • Initial complete response

    1 month

  • Initial response

    1 month

  • Number of patients with bleeding

    12 months

  • Number of patients with adverse events

    12 months

  • Time to response (TTR)

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Zanubrutinib and HD-DXM

EXPERIMENTAL

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

Drug: ZanubrutinibDrug: Dexamethasone

HD-DXM

ACTIVE COMPARATOR

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)

Drug: Dexamethasone

Interventions

ZanubrutinibDRUG

Zanubrutinib 80mg qd po, 6 consecutive weeks

Also known as: BTK inihibitor
Zanubrutinib and HD-DXM
DexamethasoneDRUG

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)

Also known as: HD-DXM
HD-DXMZanubrutinib and HD-DXM

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 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.

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, md

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, MD

CONTACT

+8613522338836zhangxh100@sina.com

Qiusha Huang, MD

CONTACT

+8613051816058huangfuqs@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

June 1, 2022

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

May 11, 2022

Record last verified: 2022-05