idiopathic multicenter Castleman disease
Conditions
Interventions
Test group:Rituximab plus cyclophosphamide and dexamethasone
Sponsors
The first affiliated hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) A diagnosis of severe idiopathic multicentric Castleman disease (iMCD-severe) without any medication for Castleman disease was required prior to enrollment. The diagnostic criteria refer to the expert consensus on diagnosis and treatment of Castleman disease in China (2021 edition). 2) ECOG score should be 0-2 during screening (Table 1). 3) Age 18-70. 4) Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)=50% (AHA 2016). 5) Life expectancy >6 months. 6) Understand the study and sign the informed consent, and can understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1) Patients who are not suitable for or unable to tolerate RCD therapy. 2) Patients with clinically significant active cardiovascular disease with diseases associated with abnormal functions of the heart, lung, liver, kidney and other organs that may limit their participation in this trial (such as advanced infection, uncontrolled diabetes, severe cardiac insufficiency or angina pectoris, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, severe renal insufficiency, etc.), Such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale ( Table 2), or a history of myocardial infarction in the 6 months prior to screening. 3) Have a history of other malignant tumors in the past 5 years; 4) Other serious medical conditions that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes). 5) Known HIV infection, or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive). 6) Pregnant or lactating women. 7) Unable to understand and follow the research protocol or unable to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total response rate (PR+CR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Duration of Response (DOR);PFS;Safety; | — |
Countries
China
Contacts
Public ContactHaitao Meng, Lianghsun You
The first affiliated hospital of Zhejiang University
Outcome results
None listed