Zanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial (NCT04743687) | Clinical Trial Compass
UnknownPhase 2
Zanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial
China30 participantsStarted 2021-01-01
Plain-language summary
To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castleman's disease (iMCD) patients.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fracti…
What they're measuring
1
Overall response rate (ORR) at Week 12
Timeframe: From date of treatment initiation to 12 weeks after treatment
2
Overall response rate (ORR) at Week 24
Timeframe: From date of treatment initiation to 24 weeks after treatment