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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03043105
• Date of registration: 31/01/2017
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
• Scientific title: Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
• Date of first enrolment: January 1, 2017
• Target sample size: 25
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03043105
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Key inclusion & exclusion criteria

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multicentric Castleman Disease

Intervention(s)

Drug: Thalidomide, cyclophosphamide and prednisone

Primary Outcome(s)

Number of Patients With Durable Tumor and Symptomatic Response [Time Frame: From baseline to the time point when a patient achieves treatment response for 24 weeks.]

Secondary Outcome(s)

Change in SF-36 Score [Time Frame: From baseline to 24 weeks after treatment.]

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( =1 Grade) [Time Frame: From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.]

Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( =3 Grade) [Time Frame: From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.]

Overall Survival [Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months.]

Progression-free Survival [Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]

Secondary ID(s)

ZS-1159

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03043105