TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Cyclophosphamide; Prednisone; Thalidomide

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.