NCT03043105

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

Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

• Multicentric Castleman Disease

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-01-01
• Completion: 2021-01-01
• First posted: 2017-02-03
• Last updated: 2020-04-16
• Results posted: 2020-04-16

Locations

1 site across 1 country: China