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

NCT03043105 | Unknown Phase 2 Results

• 1 other identifier: ZS-1159
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multicentric Castleman Disease

Keywords

Multicentric Castleman's Disease; Thalidomide, cyclophosphamide and prednisone (TCP regimen); Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Durable Tumor and Symptomatic Response

  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.

  From baseline to the time point when a patient achieves treatment response for 24 weeks.

Secondary Outcomes (5)

• Progression-free Survival

  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

• Overall Survival

  From date of randomization until the date of death from any cause, assessed up to 36 months.

• Change in SF-36 Score

  From baseline to 24 weeks after treatment.

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade)

  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)

  From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.

Study Arms (1)

TCP regimen

EXPERIMENTAL

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

Drug: Thalidomide, cyclophosphamide and prednisone

Interventions

Thalidomide, cyclophosphamide and prednisone 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.

Also known as: TCP regimen

TCP regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

Related Publications (1)

• Zhang L, Zhao AL, Duan MH, Li ZY, Cao XX, Feng J, Zhou DB, Zhong DR, Fajgenbaum DC, Li J. Phase 2 study using oral thalidomide-cyclophosphamide-prednisone for idiopathic multicentric Castleman disease. Blood. 2019 Apr 18;133(16):1720-1728. doi: 10.1182/blood-2018-11-884577. Epub 2019 Feb 13.

  PMID: 30760451 DERIVED

MeSH Terms

Conditions

Multi-centric Castleman's Disease

Interventions

Thalidomide; Cyclophosphamide; Prednisone

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Jian Li
• Organization: Peking Union Medical College Hospital

lijian@pumch.cn

86-010-69155027

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: open-labeled
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor in hematology

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

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 3, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 16, 2020
• Results First Posted: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)