Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284122
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-02-14
Brief Title:
Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body Chemotherapy in Follicular Lymphoma FLIPI2-5
Sponsor:
The Lymphoma Academic Research Organisation
Organization:
The Lymphoma Academic Research Organisation
Study Overview
Official Title:
A Phase III Randomized Open-label International Multicenter Study Evaluating the Efficacy and Safety of Mosunetuzumab Plus Lenalidomide in Comparison to Anti-CD20 Monoclonal Antibody Plus Chemotherapy in Subjects With Previously Untreated FLIPI 2-5 Follicular Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-10
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:
MorningLyte
Brief Summary:
This study is a phase III randomized open-label international multicenter interventional trial designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody mAb plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma
Detailed Description:
This study is a phase III randomized open-label international multicenter interventional trial designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody mAb plus chemotherapy in patients with previously untreated Follicular Lymphoma International Prognostic Index FLIPI 2-5 follicular lymphoma This study is composed of a screening period up to 6 weeks before randomization ie 42 days a treatment period 30 months ie 125w a safety follow-up period 90 days ie 3 months and a survival follow-up period up to 7 years after the last randomized patient The enrollment will last approximately 34 months The total duration of the study will be therefore approximately 10 years
Once a patient provides written consent they may enter the screening phase with a duration up to 6 weeks prior to randomization and initiation of treatment
Upon completion of the required assessments in the screening phase and fulfillment of the eligibility criteria patients will be randomized Investigators will be requested to indicate their treatment choice among permitted immuno-chemotherapy regimens just before randomization
The treatment period for each patient starts with the first intake The patients will receive protocol-specified treatments until
inability to achieve a response at the end of induction phase at M12 evaluation for experimental arm and at M6 evaluation for control arms
relapse or progression of the disease
withdrawal of consent
or unacceptable toxicity
In the experimental arm patients will be treated for 1 cycle of 3 weeks for mosunetuzumab and then 11 cycles of 4 weeks for mosunetuzumab and lenalidomide 47 weeks around 11 months during the induction phase and for a maximum of 9 additional cycles of 8 weeks during the maintenance phase 72 weeks around 17 months up to around 125 weeks 30 months Patients should start the maintenance phase 7 to 8 weeks after the start of last induction cycle C12
In the control arm patients will be treated for 8 or 6 cycles of 3 or 4 weeks for anti-CD20 mAb cyclophosphamide-doxorubicine-vincristine-prednisone CHOP or anti-CD20 mAb Bendamustine respectively depending on the assigned arm 24 weeks around 5 months during the induction phase and for a maximum of 12 additional cycles of 8 weeks during the maintenance phase 96 weeks around 22 months up to around 125 weeks 30 months Patients should start the maintenance phase 6 to 7 or 7 to 8 weeks after the start of last induction cycle C8 or C6
The option to cross-over from the control arm to the experimental arm is not allowed
All randomized patients will be followed for progression-free survival and overall survival using the same schedule Patients will be followed up from End of treatment evaluation every 3 months during the first two years then every 6 months during the next 3 years then yearly until the end of study
The end of study will occur when all randomized patients have been followed-up for survival for at least 7 years or discontinued study early
Once a patient provides written consent they may enter the screening phase with a duration up to 6 weeks prior to randomization and initiation of treatment
Upon completion of the required assessments in the screening phase and fulfillment of the eligibility criteria patients will be randomized Investigators will be requested to indicate their treatment choice among permitted immuno-chemotherapy regimens just before randomization
The treatment period for each patient starts with the first intake The patients will receive protocol-specified treatments until
inability to achieve a response at the end of induction phase at M12 evaluation for experimental arm and at M6 evaluation for control arms
relapse or progression of the disease
withdrawal of consent
or unacceptable toxicity
In the experimental arm patients will be treated for 1 cycle of 3 weeks for mosunetuzumab and then 11 cycles of 4 weeks for mosunetuzumab and lenalidomide 47 weeks around 11 months during the induction phase and for a maximum of 9 additional cycles of 8 weeks during the maintenance phase 72 weeks around 17 months up to around 125 weeks 30 months Patients should start the maintenance phase 7 to 8 weeks after the start of last induction cycle C12
In the control arm patients will be treated for 8 or 6 cycles of 3 or 4 weeks for anti-CD20 mAb cyclophosphamide-doxorubicine-vincristine-prednisone CHOP or anti-CD20 mAb Bendamustine respectively depending on the assigned arm 24 weeks around 5 months during the induction phase and for a maximum of 12 additional cycles of 8 weeks during the maintenance phase 96 weeks around 22 months up to around 125 weeks 30 months Patients should start the maintenance phase 6 to 7 or 7 to 8 weeks after the start of last induction cycle C8 or C6
The option to cross-over from the control arm to the experimental arm is not allowed
All randomized patients will be followed for progression-free survival and overall survival using the same schedule Patients will be followed up from End of treatment evaluation every 3 months during the first two years then every 6 months during the next 3 years then yearly until the end of study
The end of study will occur when all randomized patients have been followed-up for survival for at least 7 years or discontinued study early
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None