BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    30
  • sponsor
    Peking Union Medical College Hospital
Updated on 23 January 2021

Summary

To explore the effectiveness and safety of bortezomib, cyclophosphamide and dexamethasone (BCD regimen) in newly diagnosed idiopathic Multicentric Castleman's disease (iMCD) patients.

Description

This will be a single center, open-labeled, single arm, phase-II pilot study. The treatment and the response evaluation phase will last from the time of enrollment up to 21 months (evaluation will be carried out every 3 months in the first 9 months and every 6 months from Month 9 to Month 21). The maintenance and follow-up phase to assess for progression of disease will last from 21 months to 45 months 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.

Details
Condition Idiopathic Multicentric Castleman's Disease
Treatment cyclophosphamide, Bortezomib, dexamethason
Clinical Study IdentifierNCT03982771
SponsorPeking Union Medical College Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Idiopathic Multicentric Castleman's Disease?
Do you have any of these conditions: Do you have Idiopathic Multicentric Castleman's Disease??
Demography: 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 iMCD 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; iMCD diagnosis is based on the international consensus diagnostic criteria)
Clinical laboratory values meeting these criteria at screening: absolute neutrophil count 10 x 109/L, Platelets 50 x 109/L, Alanine aminotransferase (ALT) within 25 x upper limit of normal (ULN); total bilirubin within 25 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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note