Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521996
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
M-CHOP in Richters Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CHOP Plus Mosunetuzumab as First Line in Patients With Richters Syndrome a Phase II Study of the Spanish CLL Group
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GELLC-9Richter
Brief Summary:
The purpose of the study is to assess the efficacy safety and tolerability of mosunetuzumab combined with CHOP in patients with untreated DLBCL-RS syndrome identifying biological factors to address the probability of response
In addition efficacy and tolerability of maintenance with mosunetuzumab in patients not receiving an allo-SCT will be ascertained
In addition efficacy and tolerability of maintenance with mosunetuzumab in patients not receiving an allo-SCT will be ascertained
Detailed Description:
The primary study objective and associated endpoint is to evaluate the efficacy of mosunetuzumab combined with CHOP M-CHOP after the end of induction EoI in patients with RS who have never received therapy
Primary endpoint will be complete remission CR evaluated by an independent review committee according to modified Lugano classification using PETCT scan after the EoI visit CR is defined as a score of 1 2 or 3 for lymph nodes and extra-lymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose FDG-avid disease in bone marrow All PET evaluable in patients with at least one dose of mosunetuzumab will be included in the efficacy population
The secondary study objectives and associated endpoints are
To evaluate the efficacy of mosunetuzumab combined with CHOP M-CHOP after the end of induction EoI and maintenance EoM in patients with therapy naive RS
Overall response rate ORR defined as the proportion of participants with a complete response CR or partial response PR at the end of induction EoI and maintenance EoM as determined by local and independent review committee according to modified Lugano classification using PETCT scan and IWCLL criteria Hallek 2018
Complete remission CR at the EoM will be defined as a score of 1 2 or 3 no uptake above background for lymph nodes and extralymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose FDG-avid disease in bone marrow In addition patients need to have a normal blood count with normalimmunohistochemistry IHC-negative bone marrow morphology as per iwCLL criteria Hallek 2018 All PET evaluable patients with at least one dose of mosunetuzumab will be included in the efficacy population
Best overall response the best response is defined as the achievement of a PET score of 1-3 associated with a normal blood count with normalimmunohistochemistry IHC-negative bone marrow morphology as per iwCLL criteria or a PET score of 1-3 associated with incomplete recovery in blood and normalimmunohistochemistry IHC-negative bone marrow morphology evaluated at any time during the treatment induction or maintenance whichever occurs first
Minimal residual disease MRD response rate determined by the proportion of patients with MRD-negativity defined as 1 CLL cell in 10000 leukocytes assessed by flow cytometry in responders CRPR in peripheral blood PB andor bone marrow BM after the EoI and EoM
Progression free survival PFS defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause whichever occurs first PFS will be assessed by the investigator using the Lugano criteria
Overall survival OS defined as the time from first dose to death from any cause
Duration of response DoR defined as the time from best overall response the first occurrence of a documented objective response to disease progression by Lugano criteria or death from any cause whichever occurs first
To determine the incidence and severity of adverse events
Incidence of adverse events AEs number and percentage of patients with 1 or more AE
Severity of AEs according to NCI CTCAE v50 For events of CSR severity will be determined by ASTCT CSR consensus grading criteria For events of TLS the presence of laboratory andor clinical TLS will be determined according to Howard criteria
To evaluate the study treatment exposure
Treatment duration
Total dose received
Number of cycles and dose modifications
Treatment interruptions and discontinuations
Primary endpoint will be complete remission CR evaluated by an independent review committee according to modified Lugano classification using PETCT scan after the EoI visit CR is defined as a score of 1 2 or 3 for lymph nodes and extra-lymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose FDG-avid disease in bone marrow All PET evaluable in patients with at least one dose of mosunetuzumab will be included in the efficacy population
The secondary study objectives and associated endpoints are
To evaluate the efficacy of mosunetuzumab combined with CHOP M-CHOP after the end of induction EoI and maintenance EoM in patients with therapy naive RS
Overall response rate ORR defined as the proportion of participants with a complete response CR or partial response PR at the end of induction EoI and maintenance EoM as determined by local and independent review committee according to modified Lugano classification using PETCT scan and IWCLL criteria Hallek 2018
Complete remission CR at the EoM will be defined as a score of 1 2 or 3 no uptake above background for lymph nodes and extralymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose FDG-avid disease in bone marrow In addition patients need to have a normal blood count with normalimmunohistochemistry IHC-negative bone marrow morphology as per iwCLL criteria Hallek 2018 All PET evaluable patients with at least one dose of mosunetuzumab will be included in the efficacy population
Best overall response the best response is defined as the achievement of a PET score of 1-3 associated with a normal blood count with normalimmunohistochemistry IHC-negative bone marrow morphology as per iwCLL criteria or a PET score of 1-3 associated with incomplete recovery in blood and normalimmunohistochemistry IHC-negative bone marrow morphology evaluated at any time during the treatment induction or maintenance whichever occurs first
Minimal residual disease MRD response rate determined by the proportion of patients with MRD-negativity defined as 1 CLL cell in 10000 leukocytes assessed by flow cytometry in responders CRPR in peripheral blood PB andor bone marrow BM after the EoI and EoM
Progression free survival PFS defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause whichever occurs first PFS will be assessed by the investigator using the Lugano criteria
Overall survival OS defined as the time from first dose to death from any cause
Duration of response DoR defined as the time from best overall response the first occurrence of a documented objective response to disease progression by Lugano criteria or death from any cause whichever occurs first
To determine the incidence and severity of adverse events
Incidence of adverse events AEs number and percentage of patients with 1 or more AE
Severity of AEs according to NCI CTCAE v50 For events of CSR severity will be determined by ASTCT CSR consensus grading criteria For events of TLS the presence of laboratory andor clinical TLS will be determined according to Howard criteria
To evaluate the study treatment exposure
Treatment duration
Total dose received
Number of cycles and dose modifications
Treatment interruptions and discontinuations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None