Intense Monitoring Study on Tyvyt

Relapsed or Refractory Classical Hodgkin's Lymphoma Clinical Trial

Official title:

Intense Monitoring Study on Sintilimab Injection (Tyvyt®)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237233
• Other study ID #: CIBI308B401
• Status: Recruiting
• Start date: April 2, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Lei Zhao
• Phone: +86 021 31837200
• Email: lei.zhao01[@]innoventbio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients must be able to understand and voluntarily sign the informed consent form (ICF).

Patients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up.

Patients must have agreed to use Tyvyt® to treat the target indication.

Exclusion Criteria:

Patients refuse to be included in the study or refuse to cooperate.

Patients have participated in another interventional studies within 4 weeks prior to enrollment.

Related Conditions & MeSH terms

• Relapsed or Refractory Classical Hodgkin's Lymphoma

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of known adverse drug reactions		During the actual Tyvyt treatment time.
Primary	Occurrence of new adverse drug reactions		During the actual Tyvyt treatment time.
Primary	Association, risk factors, severity and incidence of immune-related adverse drug reactions/events		During the actual Tyvyt treatment time.
Primary	Association, risk factors, severity and incidence of serious adverse drug reactions		During the actual Tyvyt treatment time.
Primary	Occurrence of adverse drug reactions in special population		During the actual Tyvyt treatment time.
Secondary	Overall survival (OS)		During the actual Tyvyt treatment time.