Clinical Trial: TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
Brief Summary: To explore the effectiveness and safety of thalidomide, cyclophosphamide and prednisone (TCP regimen) in newly diagnosed Multicentric Castleman's disease (MCD) patients.
Detailed Summary: 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.
Sponsor: Peking Union Medical College Hospital
Current Primary Outcome: Durable tumor and symptomatic response [ Time Frame: 12 months after the last patient begins study treatment. ]
Original Primary Outcome: Durable tumor and symptomatic response [ Time Frame: 48 weeks after the last patient begins study treatment. ]
Current Secondary Outcome:
- Progression-free survival (PFS) [ Time Frame: 12 months after the last patient begins study treatment. ]defined as the time to tumor PD
- Overall survival (OS) [ Time Frame: 12 months after the last patient begins study treatment. ]defined as the time to patients' death
- Change in SF-36 score [ Time Frame: From Day 1 of the TCP treatment until 12 months after the treatment ]SF-36 score is a self-administered scoring system which contains several aspects and reflects a patient's general health status.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 ( ≥1 grade) [ Time Frame: 12 months after the last patient begins study treatment. ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included)
- Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 ( ≥3 grade) [ Time Frame: 12 months after the last patient begins study treatment. ]Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included)
Original Secondary Outcome:
- Progression-free survival (PFS) [ Time Frame: 48 weeks after the last patient begins study treatment. ]defined as the time to tumor PD
- Overall survival (OS) [ Time Frame: 48 weeks after the last patient begins study treatment. ]defined as the time to patients' death
- Change in SF-36 score [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment ]SF-36 score is a self-administered scoring system which contains several aspects and reflects a patient's general health status.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 ( ≥1 grade) [ Time Frame: 48 weeks after the last patient begins study treatment. ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included)
- Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 ( ≥3 grade) [ Time Frame: 48 weeks after the last patient begins study treatment. ]Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included)
Information By: Peking Union Medical College Hospital
Dates:
Date Received: January 31, 2017
Date Started: January 1, 2017
Date Completion: January 1, 2021
Last Updated: February 3, 2017
Last Verified: February 2017