Clinical Trials Logo
  1. Home
  2. Classical Hodgkin Lymphoma
  3. NCT05404945

Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above

Classical Hodgkin Lymphoma Clinical Trial

Official title:
Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above (cHL 001)

Clinical Trial Summary

This is a multi-center, open-label phase II study to assess the efficacy of a novel fitness-adapted regimen in previously untreated older patients with classical Hodgkin lymphoma. All participants will receive up to a total of 8 cycles of pembrolizumab (Q6 week dosing). The first cycle of pembrolizumab will be administered in combination with brentuximab vedotin (BV) ("lead-in treatment"). Following lead-in treatment, all participants will undergo interim PET/CT (iPET) as well as fitness testing to help inform participant level of fitness for subsequent lymphoma-directed therapies. Participants deemed "non-fit" by this assessment will continue 3 additional 6 week cycles of concurrent pembrolizumab and BV ("induction therapy", each cycle is 42 days), then continue single-agent pembrolizumab to complete up to 4 additional cycles (i.e., 8 total) of therapy ("consolidation and maintenance therapy", Non-Fit cohort). Two additional BV doses will be given as consolidation, at days 1 and 22 of pembrolizumab cycle 5. Those deemed "fit" after lead-in therapy (Fit cohort) will continue pembrolizumab and switch from BV to concurrently-administered combination chemotherapy using doxorubicin (A), vinblastine (V), and dacarbazine (D) for a total of 4 planned AVD cycles (3, 6-week pembrolizumab cycles, "induction therapy"). Chemotherapy drugs will be given at standard doses as in ABVD (no bleomycin will be given in this study) on days 1 and 15 of each 28-day cycle (C1AVD), and pembrolizumab dosing will remain every 42 days. Following end-induction PET/CT, pembrolizumab will continue every 42 days for up to 4 cycles in the consolidation/maintenance phase. Two additional BV doses will be given as consolidation, at days 1 and 22 of pembrolizumab cycle 5.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05404945
Study type Interventional
Source University of Virginia
Contact Nino Mchedlishvili
Phone 434-924-9969
Email nm6s@uvahealth.org
Status Recruiting
Phase Phase 2
Start date July 26, 2022
Completion date October 3, 2027
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