Intense Monitoring Study on Tyvyt

Recruiting

• Conditions: Relapsed or Refractory Classical Hodgkin's Lymphoma

• Registration Number: NCT04237233
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Study Start: 2020-04-02
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-16
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse drug reactions in special population	During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of serious adverse drug reactions	During the actual Tyvyt treatment time.
Occurrence of new adverse drug reactions	During the actual Tyvyt treatment time.
Incidence of known adverse drug reactions	During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of immune-related adverse drug reactions/events	During the actual Tyvyt treatment time.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	During the actual Tyvyt treatment time.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China