Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    100
  • sponsor
    BeiGene
Updated on 28 June 2021
cancer
lymphoma
measurable disease
chemotherapy regimen
avid
brentuximab
refractory classical hodgkin lymphoma

Summary

The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

Details
Condition Classical Hodgkin Lymphoma
Treatment tislelizumab
Clinical Study IdentifierNCT04318080
SponsorBeiGene
Last Modified on28 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of relapsed or refractory cHL
Relapsed cHL (disease progression after PR or CR to the most recent therapy) or refractory cHL (failure to achieve PR or CR to most recent therapy). Participants will be allocated to one of two cohorts based on the following criteria
Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell
transplant (HSCT) and brentuximab vedotin
Has failed to achieve a response or progressed after autologous HSCT and failed to achieve a response or progressed after brentuximab vedotin
Is not a candidate for additional autologous or allogeneic HSCT
Cohort 2: Relapsed or refractory to salvage chemotherapy, including
brentuximab vedotin, and has not received prior autologous or allogeneic HSCT
Is not a candidate for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy
Has received at least 2 prior systemic chemotherapy regimens for cHL and failed to achieve a response or progressed after brentuximab vedotin
Measurable disease defined as 1 2-[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion that is > 1.5 cm in the longest diameter, or 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is > 1 cm in the longest diameter
Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma
Prior allogeneic hematopoietic stem cell transplantation
Prior therapy targeting PD-1 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways
Active autoimmune disease or history of autoimmune disease that may relapse
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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

0/250
Preferred Language
Other Language
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...

Browse trials for

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