Clinical Trials Logo
  1. Home
  2. Classical Hodgkin Lymphoma
  3. NCT03209973

A Study of Tislelizumab as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma

Classical Hodgkin Lymphoma Clinical Trial

Official title:
A Single Arm, Multicenter, Phase 2 Study of BGB-A317 as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma

Clinical Trial Summary

The primary objective of this study was to evaluate the efficacy of tislelizumab assessed by Independent Review Committee (IRC) in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification

Clinical Trial Description

This was an open-label, single-arm, multi-center Phase 2 study. Response was to be assessed by PET(positron emission tomography) and computed tomography (CT) scan per the Lugano Classification. CT scan with contrast and Positron emission tomography (PET)/CT was used as required by protocol, until progressive disease (PD), new anti-cancer therapy, withdrawal of consent, death, lost to follow-up, or end of study (EOS), whichever occurred first. Total body magnetic resonance imaging (MRI) was allowed if CT with contrast is contraindicated. During treatment with immune checkpoint inhibitor such as with tislelizumab, pseudo-progression may occur due to immune cell infiltration and other mechanisms as manifested by apparent increase of existing tumor masses or appearance of new tumor lesions. Participants were allowed to continue study treatment if there is suspicion of pseudo-progression, provided they are asymptomatic and have radiographic progression only, until a second consecutive CT scan demonstrates PD at which time study treatment was discontinued permanently. Participants were evaluated for Adverse Events (AEs) (all Grades per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03 [NCI CTCAE v. 4.03]), serious AEs (SAEs), and any AEs requiring study drug interruption or discontinuation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03209973
Study type Interventional
Source BeiGene
Contact
Status Completed
Phase Phase 2
Start date April 21, 2017
Completion date November 2, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06018129 - A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma Phase 1/Phase 2
Recruiting NCT03212404 - Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Phase 1
Recruiting NCT04288726 - Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas Phase 1
Recruiting NCT04486391 - Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma Phase 3
Active, not recruiting NCT05008224 - Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11) Phase 2
Active, not recruiting NCT02684708 - Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents Phase 3
Active, not recruiting NCT03226249 - PET-Directed Therapy With Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Classical Hodgkin Lymphoma Phase 2
Active, not recruiting NCT03739619 - Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT03327571 - B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes
Recruiting NCT03652441 - Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma Phase 2
Completed NCT02243436 - Brentuximab Vedotin in Pre-transplant Induction and Consolidation for Relapsed or Refractory Hodgkin Lymphoma Phase 1/Phase 2
Terminated NCT04254107 - A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer Phase 1
Recruiting NCT05714553 - NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours Phase 1/Phase 2
Completed NCT02981914 - Pilot Study of Pembrolizumab Treatment for Disease Relapse After Allogeneic Stem Cell Transplantation Early Phase 1
Withdrawn NCT04952584 - Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas Phase 1
Withdrawn NCT03205891 - Study of Brentuximab Vedotin Plus TAK228 for Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas Phase 1
Not yet recruiting NCT02808520 - Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma N/A
Recruiting NCT02332668 - A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) Phase 1/Phase 2
Completed NCT04858568 - Immune Responses to COVID-19 Vaccination in Lymphoma Patients
Active, not recruiting NCT02824029 - Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma Phase 2