Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251180
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-02-01
Brief Title:
Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma
Sponsor:
Guangzhou Lupeng Pharmaceutical Company LTD
Organization:
Guangzhou Lupeng Pharmaceutical Company LTD
Study Overview
Official Title:
A Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-NHL
Status:
RECRUITING
Status Verified Date:
2024-04
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 is an open-label multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP Rituximab Cyclophosphamide Doxorubicin Vincristin Prednison in adult patients with newly diagnosed previously untreated B-cell Non-Hodgkin Lymphoma Diffuse Large B-cell Lymphoma DLBCL Marginal Zone Lymphoma MZL or Mantle Cell Lymphoma MCL
Detailed Description:
OUTLINE
Dose escalation portionPart A In the dose escalation portion of the study the escalating doses of Rocbrutinib combined with R-CHOP may be explored using the 33 principle for dose determination If dose escalation is acceptable and subsequently will determine the recommended Phase 2 dose
Dose expansion portionPart B This will be conducted as a multicenter open-label study including three cohortsCohort 1 non-GCB DLBCL Cohort 2 MZL Cohort 3 MCL Eligible subjects will receive Rocbrutinib combined with R-CHOP for 6 cycles then Rocbrutinib plus Rituximab for 2 cycles and followed by Rocbrutinib maintenance for 2 years
After completion of study treatment patients are followed up every 12 weeks for 1 year then every 24 weeks for 4 year
PRIMARY OBJECTIVES
I To evaluate the safety of Rocbrutinib in combination to R-CHOP in B-cell Non-Hodgkin Lymphoma including the maximum tolerated dose MTD dose limiting toxicitiesDLT adverse events AEs clinically significant laboratory abnormalities
2 To determine the recommended dose 3 To determine the pharmacokinetic characteristics of Rocbrutinib in combination to R-CHOP
SECONDARY OBJECTIVES
I To determine the overall response rate the complete response rate duration of remission survival outcomes progression free survival event free survival overall survival in DLBCL Non-germinal Centernon-GCB DLBCL
2 To determine the overall response rate the complete response rate duration of remission survival outcomes progression free survival event free survival overall survival in MZL
3 To determine the overall response rate the complete response rate duration of remission survival outcomes progression free survival event free survival overall survival in MCL
Dose escalation portionPart A In the dose escalation portion of the study the escalating doses of Rocbrutinib combined with R-CHOP may be explored using the 33 principle for dose determination If dose escalation is acceptable and subsequently will determine the recommended Phase 2 dose
Dose expansion portionPart B This will be conducted as a multicenter open-label study including three cohortsCohort 1 non-GCB DLBCL Cohort 2 MZL Cohort 3 MCL Eligible subjects will receive Rocbrutinib combined with R-CHOP for 6 cycles then Rocbrutinib plus Rituximab for 2 cycles and followed by Rocbrutinib maintenance for 2 years
After completion of study treatment patients are followed up every 12 weeks for 1 year then every 24 weeks for 4 year
PRIMARY OBJECTIVES
I To evaluate the safety of Rocbrutinib in combination to R-CHOP in B-cell Non-Hodgkin Lymphoma including the maximum tolerated dose MTD dose limiting toxicitiesDLT adverse events AEs clinically significant laboratory abnormalities
2 To determine the recommended dose 3 To determine the pharmacokinetic characteristics of Rocbrutinib in combination to R-CHOP
SECONDARY OBJECTIVES
I To determine the overall response rate the complete response rate duration of remission survival outcomes progression free survival event free survival overall survival in DLBCL Non-germinal Centernon-GCB DLBCL
2 To determine the overall response rate the complete response rate duration of remission survival outcomes progression free survival event free survival overall survival in MZL
3 To determine the overall response rate the complete response rate duration of remission survival outcomes progression free survival event free survival overall survival in MCL
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?:
None
Is an FDA AA801 Violation?:
None