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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04743687
Other study ID # ZS-2551
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2025

Study information

Verified date February 2021
Source Peking Union Medical College Hospital
Contact Jian Li, M.D.
Phone +86-18610852525
Email lijian@pumch.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This is a single center, open-labeled , single arm, prospective study which includes a safety run-in phase. The primary endpoint is the overall response rate which includes complete response (CR) and partial response (PR) at Week 12 and Week 24. The secondary endpoints include progression-free survival (PFS), overall survival (OS), and adverse events. There are two phases of the study. The first phase is the 'safety run-in phase'which plans to enroll 6 patients who would be observed for safety issues for 12 weeks after study drug administration. If no Grade ≥ 4 (CTCAE) adverse events (AE) occurs during this phase, the study would enter the second phase; if Grade ≥ 4 (CTCAE) AE happens during this phase, the study would be terminated. In the second phase of the study, another 24 patients would be enrolled. All enrolled patients would receive the study drug until progression of disease, intolerability of the drugs or Week 96 and would be followed every 4 weeks in the first 12 weeks, every 12 weeks until Week 48 and every 24 weeks until Week 96. The follow-up phase to assess PFS and OS will last from initiation of study drug to 36 months after enrollment (evaluation would be carried out every 24 weeks after Week 96). The total study duration will be 4 years after the last patient starts study medication.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - taking drugs which strongly inhibit P450 CYP3A - patients or their relatives fail to understand the purpose of the study - any other conditions that the investigators consider to be not appropriate for inclusion

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zanubrutinib
Oral Zanuburutinib, 160mg twice a day

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Progression free survival Time to disease progression or death 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
Secondary Overall survival Time to death From date of treatment initiation until the date of death from any cause, whichever came first, assessed up to 36 months
Secondary Number of Participants With Treatment-related Adverse Events Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( =1 Grade) From initiation study regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05995834 - Producing a Novel Symptom Burden Scale for People Living With Idiopathic Multicentric Castleman Disease (ISBUS)
Terminated NCT04838860 - Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease Phase 2
Recruiting NCT03982771 - BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD) Phase 2
Recruiting NCT05345522 - A Study of Anti-IL-6R mAb Injection in Patients With iMCD Phase 2