Clinical Trial: NCT03580408
Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | The Lymphoma Academic Research Organisation |
| Information Provided By: | The Lymphoma Academic Research Organisation |
| Last Update Posted: | 2022-08-19 |
Study Overview
Brief Summary
This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. :
- In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12.
- In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12.
- In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.
Official Title
A Prospective Phase II Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients Aged 61 Years And Older, With Classical Hodgkin Lymphoma And Coexisting Medical Conditions.
Conditions
Hodgkin Lymphoma, Coexisting Medical Conditions
Intervention / Treatment
- Drug: Nivolumab
- Drug: Vinblastin
Other Study ID Numbers
- NIVINIHO
Start Date (Actual)
2018-08-31
Primary Completion Date (Actual)
2021-02-19
Study Completion Date (Actual)
2021-08-12
Enrollment (Actual)
64
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | The Lymphoma Academic Research Organisation |
| Information Provided By: | The Lymphoma Academic Research Organisation |
| Last Update Posted: | 2022-08-19 |
Study Overview
Brief Summary
This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. :
- In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12.
- In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12.
- In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.
Official Title
A Prospective Phase II Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients Aged 61 Years And Older, With Classical Hodgkin Lymphoma And Coexisting Medical Conditions.
Conditions
Hodgkin Lymphoma, Coexisting Medical Conditions
Intervention / Treatment
- Drug: Nivolumab
- Drug: Vinblastin
Other Study ID Numbers
- NIVINIHO
Start Date (Actual)
2018-08-31
Primary Completion Date (Actual)
2021-02-19
Study Completion Date (Actual)
2021-08-12
Enrollment (Actual)
64
Study Type
Interventional
Phase
Phase 2