Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557330
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
MRD Guided De-intensification of BendamustineRituximab for Indolent Non-Hodgkin Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HM-225 Measurable Residual Disease MRD Guided De-intensification of BendamustineRituximab BR for Indolent Non-Hodgkin Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is a phase II pilot single arm open label study designed to assess the efficacy safety and feasibility of MRD adapted duration of BR for untreated or RR iNHL
Detailed Description:
This is a phase II pilot single arm open label study designed to assess the efficacy safety and feasibility of MRD adapted duration of BR for untreated or RR iNHL
All patients with untreated or RR not previously treated with Bendamustine iNHL Follicular Lymphoma Grade 1-3a2 Marginal Zone Lymphoma Lymphoplasmacytic Lymphoma are candidates for this trial Patients requiring treatment per treating physicians discretion are eligible for the trial
Patients who recently started on and received two cycles of Bendamustine at 90 mgm2 dose with Ritxumab 375 mgm2 are also eligible for this trial For these patients C2D1 BR should be no more than 14 days prior to the time of study enrollment ie enrollment no later than C2D14 Patients who have received two cycles of 90mgm2 Bendamustine dose with Rituximab 375 mgm2 can enter the study and initiate cycle 3 once pre-screening and screening procedures have been completed
All patients with untreated or RR not previously treated with Bendamustine iNHL Follicular Lymphoma Grade 1-3a2 Marginal Zone Lymphoma Lymphoplasmacytic Lymphoma are candidates for this trial Patients requiring treatment per treating physicians discretion are eligible for the trial
Patients who recently started on and received two cycles of Bendamustine at 90 mgm2 dose with Ritxumab 375 mgm2 are also eligible for this trial For these patients C2D1 BR should be no more than 14 days prior to the time of study enrollment ie enrollment no later than C2D14 Patients who have received two cycles of 90mgm2 Bendamustine dose with Rituximab 375 mgm2 can enter the study and initiate cycle 3 once pre-screening and screening procedures have been completed
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