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. ]

Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months.


Original Primary Outcome: Durable tumor and symptomatic response [ Time Frame: 48 weeks after the last patient begins study treatment. ]

Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.


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