Relapsed or Refractory Classical Hodgkin's LymphomaNCT04237233
Intense Monitoring Study on Tyvyt
An observational study of Relapsed or Refractory Classical Hodgkin's Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsed or Refractory Classical Hodgkin's Lymphoma
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
About this study
Official title: 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.
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of known adverse drug reactions
Measured: During the actual Tyvyt treatment time.
Occurrence of new adverse drug reactions
Measured: During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of immune-related adverse drug reactions/events
Measured: During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of serious adverse drug reactions
Measured: During the actual Tyvyt treatment time.
Occurrence of adverse drug reactions in special population
Measured: During the actual Tyvyt treatment time.
Secondary outcomes (1)
Overall survival (OS)
Measured: During the actual Tyvyt treatment time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start2 Apr 2020
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Classical Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237233
- Sponsor's protocol ID
- CIBI308B401
- Status last verified
- Sep 2022
- First submitted
- 31 Dec 2019
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense Monitoring Study on Sintilimab Injection (Tyvyt®)
- ClinicalTrials.gov ID
- NCT04237233
- Acronym / sponsor ID
- CIBI308B401
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of known adverse drug reactions
Time frame: During the actual Tyvyt treatment time.
Occurrence of new adverse drug reactions
Time frame: During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of immune-related adverse drug reactions/events
Time frame: During the actual Tyvyt treatment time.
Association, risk factors, severity and incidence of serious adverse drug reactions
Time frame: During the actual Tyvyt treatment time.
Occurrence of adverse drug reactions in special population
Time frame: During the actual Tyvyt treatment time.
1 secondary outcome
Overall survival (OS)
Time frame: During the actual Tyvyt treatment time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Classical Hodgkin's Lymphoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhao (+86 021 31837200, lei.zhao01@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of known adverse drug reactions (time frame: During the actual Tyvyt treatment time.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.