TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial (NCT03043105) | Clinical Trial Compass
UnknownPhase 2
TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
China25 participantsStarted 2017-01-01
Plain-language summary
To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 preg…
What they're measuring
1
Number of Patients With Durable Tumor and Symptomatic Response
Timeframe: From baseline to the time point when a patient achieves treatment response for 24 weeks.