Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647940
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL PatientsRocket Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients a Single-arm Multicenter Phase II Clinical TrialRocket Trial
Status:
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 prospective single-arm multicenter phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP rituximab cyclophosphamide vincristine doxorubicin and prednisone regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma DLBCL patients
Detailed Description:
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients
The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP orelabrutinib added from the second cycle followed by 2 cycles of rituximab orelabrutinib for a total of 8 treatment cycles After 8 cycles of induction therapy if the response is assessed as complete remission CR maintenance therapy with orelabrutinib will be conducted
The primary endpoint is the 2-year event-free survival EFS rate
The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP orelabrutinib added from the second cycle followed by 2 cycles of rituximab orelabrutinib for a total of 8 treatment cycles After 8 cycles of induction therapy if the response is assessed as complete remission CR maintenance therapy with orelabrutinib will be conducted
The primary endpoint is the 2-year event-free survival EFS rate
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