Intense Monitoring Study on Tyvyt

Intense Monitoring Study on Sintilimab Injection (Tyvyt®)

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory Classical Hodgkin's Lymphoma

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Lei Zhao; Phone Number: +86 021 31837200; Email: lei.zhao01@innoventbio.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The main study population is target indication patients treated with Tyvyt® within the territory of China. If any new indication is approved during the implementation of the project, and there are no special requirements for the approval, the new indication patients using Tyvyt® will also be included in the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of known adverse drug reactions	During the actual Tyvyt treatment time.
Occurrence of new 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.
Association, risk factors, severity and incidence of serious adverse drug reactions	During the actual Tyvyt treatment time.
Occurrence of adverse drug reactions in special population	During the actual Tyvyt treatment time.

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	During the actual Tyvyt treatment time.

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2020
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CIBI308B401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No