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

Study Results

Results available

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-01-01

Brief Summary

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

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Detailed Description

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This is a single center, open-labeled , single arm, phase-II pilot study which aims to evaluate the efficacy and safety of thalidomide, cyclophosphamide and prednisone (TCP regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.There would be two phases of the study. The treatment and the response evaluation phase will last from the time of enrollment up to 24 months (evaluation will be carried out every 3 months). The follow-up phase to assess for progression of disease will last from 24 months (2 years) to 4 years after enrollment (evaluation will be carried out every 12 months).The total study duration will be 4 years after the last patient starts study medication.

Conditions

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Multicentric Castleman Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This will be a single center, single arm, phase-II pilot study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open-labeled

Study Groups

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TCP regimen

Thalidomide, cyclophosphamide and prednisone （TCP regimen）would be used for newly-diagnosed symptomatic MCD patients

Group Type EXPERIMENTAL

Thalidomide, cyclophosphamide and prednisone

Intervention Type DRUG

* 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.

Interventions

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Thalidomide, cyclophosphamide and prednisone

* 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 Type DRUG

Other Intervention Names

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TCP regimen

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No