Zanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial

NCT04743687 | Unknown Phase 2

• 1 other identifier: ZS-2551
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castleman's disease (iMCD) patients.

Conditions

Idiopathic Multicentric Castleman's Disease

Keywords

iMCD; Zanuburutinib; efficacy; safety

Outcome Measures

Primary Outcomes (2)

• Overall response rate (ORR) at Week 12

  Overall response (including partial response and complete response) rate at week 12 after zanuburutinib therapy

  From date of treatment initiation to 12 weeks after treatment

• Overall response rate (ORR) at Week 24

  Overall response (including partial response and complete response) rate at week 24 after zanuburutinib therapy

  From date of treatment initiation to 24 weeks after treatment

Secondary Outcomes (3)

• Progression free survival

  From date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

• Overall survival

  From date of treatment initiation until the date of death from any cause, whichever came first, assessed up to 36 months

• Number of Participants With Treatment-related Adverse Events

  From initiation study regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy

Study Arms (1)

Zanuburutinib

EXPERIMENTAL

Oral Zanuburutinib 160mg twice a day

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

Oral Zanuburutinib, 160mg twice a day

Also known as: brukinsa

Zanuburutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fulfilled the CDCN (Castleman Disease Collaborative Network) diagnostic criteria of iMCD
• relapsed or refractory disease. Relapsed = patients who ever achieved overall partial response (PR) or complete response (CR) with prior lines of therapy suffered from progressive disease (PD); refractory = iMCD patients who never achieved PR or CR with the first-line treatment but suffered from PD during treatment.
• Eastern Cooperative Oncology Group performance status (ECOG-PS ≤ 2)
• Neutrophil count ≥ 0.75×10\^9/L, hemoglobin ≥ 70 g/L and platelet count \> 30×10\^9/L
• Total bilirubin ≤ 2 x ULN (upper limit of normal), AST（aspartate aminotransferase） or ALT（Alanine aminotransferase）≤ 2.5 x ULN
• INR （international normalized ratio) and APTT(activated partial thromboplastin time) ≤ 1.5 x ULN；eGFR\>25ml/min/1.73m2
• estimated survival ≥ 3 months
• agree to take birth control methods during study period for women of reproductive age
• agree to provide informed consent

You may not qualify if:

• concurrent malignancies
• prior history of receiving any kind of BTK (Bruton's tyrosine kinase) inhibitors
• patients with SLE (systemic lupus erythematosus), HHV-8 (human herpesvirus-8) infection or POEMS syndrome
• History of major surgery or radiation therapy within 4 weeks before initiation of study drug
• history of myocardial infarction within 1 years
• patient with history of heart failure (NYHA 3 or 4) would be excluded unless his LVEF(left ventricular ejection fraction) ≥ 50% within 1 months
• primary cardiomyopathy; Qtc \> 450ms for men and \> 470ms for women
• breast feeding or pregnant women
• intolerance for oral regimen due to gastro-intestinal disorders
• uncontrolled infection
• positive HBV(hepatitis B virus)-DNA titers or positive HbsAg; positive HCV(hepatitis C virus)antibody; patients with HIV infection
• patients with history of bleeding disorders
• cerebral infarction or intracranial bleeding within 6 months
• active bleeding disorders within 2 months
• taking anti-platelet or anticoagulation drugs

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (1)

• Zhang L, Gao YH, Li SY, Zhao H, Zhang MY, Yu YY, Liu YT, Li J. A prospective study of zanubrutinib, a Bruton tyrosine kinase inhibitor, in relapsed/refractory idiopathic multicentric Castleman disease. Int J Hematol. 2024 Jun;119(6):631-637. doi: 10.1007/s12185-024-03747-7. Epub 2024 Mar 28.

  PMID: 38546960 DERIVED

MeSH Terms

Conditions

Multi-centric Castleman's Disease

Interventions

zanubrutinib

Central Study Contacts

Jian Li, M.D.

CONTACT

+86-18610852525; lijian@pumch.cn

Lu Zhang, M.D.

CONTACT

+86-18610728815; pumczhanglu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This will be an open label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a single center, single arm, phase 2 study.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)