Classical Hodgkin Lymphoma Clinical Trial
Official title:
European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
The EuroNet-PHL-C2 trial is an international, multicentre, randomised controlled trial with the aims to reduce the indication for radiotherapy in newly diagnosed patients with classical Hodgkin lymphoma without compromising cure rates and to investigate a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkin lymphoma to compensate for reduction in radiotherapy.
EuroNet-PHL-C2 is a comprehensive treatment strategy for all first line classical Hodgkin Lymphoma (cHL) patients under 18 years (under 25 years in UK, Italy and France). The overall strategy is risk stratified (defining chemotherapy) and response adapted (defining radiotherapy) to tailor the amount of treatment to the individual patient and decrease long term complications. - Radiotherapy indication will be restricted. Patients with a negative PET scan after two cycles of OEPA chemotherapy (Early Response Assessment - ERA) will not receive radiotherapy. The threshold for negative PET scan at ERA shifts from the previously used Deauville 1 and 2 = negative (as in the C1 trial) to Deauville 1, 2 and 3 = negative, thereby increasing the number of negative patients without indication for RT. - Chemotherapy Randomisation All intermediate (TL-2) and advanced stage (TL-3) patients will be randomised between respectively 2 or 4 standard COPDAC-28 or intensified DECOPDAC-21 consolidation chemotherapy cycles. To avoid delayed consolidation, randomisation has to be performed before ERA and as soon as the TL-assignment is confirmed by central review. Therefore two randomised sub-studies arise based on the ERA PET response: Patients with adequate response at ERA do not receive radiotherapy - a randomised controlled chemotherapy comparison to show that intensified DECOPDAC-21 consolidation chemotherapy improves EFS as compared to standard COPDAC-28 Patients with inadequate response at ERA - a randomised controlled chemotherapy-radiotherapy comparison - to show that DECOPDAC-21 combined with radiotherapy restricted to sites that remain FDG-PET positive at the end of all chemotherapy (Late response assessment - LRA) has comparable EFS compared to COPDAC-28 plus standard involved node radiotherapy as in the C1 trial. - Risk stratification is refined Former treatment groups (TG) of the EuroNet-PHL-C1 trial are reassigned into treatment levels (TL) by shifting early stage patients (former TG-1) with risk factors into TL-2. - Semi-quantitative 'qPET' Results of semi-quantitative qPET are formally integrated into the response assessment. ;
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 |
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 | |
Recruiting |
NCT05900765 -
A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma
|
Phase 2 |