Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772624
Status:
RECRUITING
Last Update Posted:
2023-03-16
First Post:
2023-02-13
Brief Title:
Lowdose Nivolumab in Combination With AVD as Front Line Therapy for Classic Hodgkins Lymphoma
Sponsor:
Hospital Universitario Dr Jose E Gonzalez
Organization:
Hospital Universitario Dr Jose E Gonzalez
Study Overview
Official Title:
Safety and Efficacy Evaluation of Low-dose Nivolumab in Combination With AVD as Frontline Therapy for Classic Hodgkins Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to prove the efficacy and safety of low dose nivolumab 40mg as the lowest available presentation in combination with AVD adriamycinvinblastine sulfate and dacarbazine as frontline treatment for classic Hodgkins lymphoma
Detailed Description:
The main objective of this project is to prove the efficacy and safety of Nivolumab used as an standard dose of 40mg as the lowest available presentation in combination with AVD as frontline therapy for Hodgkins lymphoma
Patients classification
We will categorize patients in three groups as follows
1 Early stages by Ann-arbor classification III with no risk factors as stablished by NCCNs guidelines criteria
2 Early stages by Annarbor classification III with risk factors as stablished by NCCNs guidelines criteria
3 Advanced stages by Ann-arbor classification IIIIV
Methodology
Patients will receive two initial cycles of NAVD therapy each with two applications in day 1 and 15 and then will be evaluated with an interim PETCT after completing cycle 2
According to the PET CT results patients will be categorized as fast responsers patients who achieve Deauville 1-3 classification and low responsers patients who achieve Deauville 4-5
Fast responsers will receive following cycles without nivolumab 2 extra cycles for patients categorized as early stage with no risk factors 4 extra cycles for patients categorized as early stages with risk factors and for advanced stages
Patients will receive medical evaluation at first meeting during their treatment and after conclusion of the treatment with physical examination and laboratory tests according to medical criteria
Adverse effects will be recorded and managed following the guidelines for immunotherapy and chemotherapy indications
Patients classification
We will categorize patients in three groups as follows
1 Early stages by Ann-arbor classification III with no risk factors as stablished by NCCNs guidelines criteria
2 Early stages by Annarbor classification III with risk factors as stablished by NCCNs guidelines criteria
3 Advanced stages by Ann-arbor classification IIIIV
Methodology
Patients will receive two initial cycles of NAVD therapy each with two applications in day 1 and 15 and then will be evaluated with an interim PETCT after completing cycle 2
According to the PET CT results patients will be categorized as fast responsers patients who achieve Deauville 1-3 classification and low responsers patients who achieve Deauville 4-5
Fast responsers will receive following cycles without nivolumab 2 extra cycles for patients categorized as early stage with no risk factors 4 extra cycles for patients categorized as early stages with risk factors and for advanced stages
Patients will receive medical evaluation at first meeting during their treatment and after conclusion of the treatment with physical examination and laboratory tests according to medical criteria
Adverse effects will be recorded and managed following the guidelines for immunotherapy and chemotherapy indications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None