TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
Condition: Multicentric Castleman Disease
MeSH terms: Castleman Disease
Intervention: Thalidomide, cyclophosphamide and prednisone
Intervention description: Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
Intervention MeSH terms: Thalidomide; Prednisone; Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This will be a single center, single arm, phase-II pilot study.
Masking: None (Open Label)
Masking description: open-labeled
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multicentric Castleman's Disease; Thalidomide, cyclophosphamide and prednisone (TCP regimen); Efficacy; Safety

Summary:

      To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP
      regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.
    

Eligibility criteria:

        -  Inclusion Criteria:

               -  ≥18 years, all race/ethnic groups in China；

               -  Newly diagnosed and previously untreated (patients are allowed to have received
                  oral prednisone for up to 1 week before enrollment) symptomatic MCD patients
                  (symptomatic disease is defined by the presence of clinical symptoms with the
                  NCI-CTCAE grading ≥1 that are attributable to the disease, and for which
                  treatment is indicated);

               -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;

               -  Clinical laboratory values meeting these criteria at screening: absolute
                  neutrophil count ≥ 1•0 x 109/L, Platelets ≥ 50 x 109/L, Alanine aminotransferase
                  (ALT) within 2•5 x upper limit of normal (ULN); total bilirubin within 2•5 x ULN;
                  estimated glomerular filtration rate (according to MDRD formula) <15ml/min;

               -  Women of childbearing potential must agree to use birth control measures during
                  the study and for at least 3 months after receiving the last dose of study agent,
                  and must have a negative pregnancy test at screening period. Men must agree to
                  use birth control measures during the study and for at least 3 months after
                  receiving the last dose of study agent;

               -  Informed consent must be signed.

          -  Exclusion Criteria:

               -  age under 18 years;

               -  ECOG (eastern cooperative oncology group) status above 2;

               -  Immunosuppressive or anti-neoplastic drugs within the last 3 months;

               -  serious diseases including malignancy;

               -  Plan to have babies within 1 year after enrollment (for women and men), or
                  pregnancy / breast-feeding (for women);

               -  Known hypersensitivity to study agents;

               -  Active infection requiring systemic treatment;

               -  Other severe concurrent disease (eg. uncontrolled diabetes, symptomatic coronary
                  heart disease) that is likely to interfere with study procedures or results, or
                  that in the opinion of the investigator would constitute a hazard for
                  participating in this study;

               -  Unwilling or unable to provide informed consent;

               -  Unwilling to return for follow-up at PUMCH.