Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287398
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-07
Brief Title:
Epcoritamab Epcor-Containing Combination Salvage Therapy Followed by ASCT Epcor Consolidation in Patients With Relapsed LBCL
Sponsor:
Australasian Leukaemia and Lymphoma Group
Organization:
Australasian Leukaemia and Lymphoma Group
Study Overview
Official Title:
A Trial to Assess the Safety and Efficacy of Epcoritamab-containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma followed by autologous stem-cell transplantation ASCT and consolidation Epcoritamab The main questions it aims to answer are
Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory RR large B-cell lymphoma who achieve a complete remission prior to planned transplant
Is consolidation epcoritamab after ASCT deliverable and safe
Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease
Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival PFS and event free survival EFS at 12 months compared to historical estimates in this population
Participants will undergo three phases in this trial
1 Epcoritamab-Salvage treatment consists of 3 cycles of R-DHAOx rituximab dexamethasone cytarabine oxaliplatin plus Epcoritamab
2 ASCT Pre-autograft eligibility assessment for ASCT will be performed according to local practice ASCT may be administered at local referring centre and will follow local standard operative procedures
3 Consolidation treatment consists of six 28-day cycles of subcutaneous Epcoritamab commencing 6 - 12 weeks post ASCT
Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory RR large B-cell lymphoma who achieve a complete remission prior to planned transplant
Is consolidation epcoritamab after ASCT deliverable and safe
Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease
Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival PFS and event free survival EFS at 12 months compared to historical estimates in this population
Participants will undergo three phases in this trial
1 Epcoritamab-Salvage treatment consists of 3 cycles of R-DHAOx rituximab dexamethasone cytarabine oxaliplatin plus Epcoritamab
2 ASCT Pre-autograft eligibility assessment for ASCT will be performed according to local practice ASCT may be administered at local referring centre and will follow local standard operative procedures
3 Consolidation treatment consists of six 28-day cycles of subcutaneous Epcoritamab commencing 6 - 12 weeks post ASCT
Detailed Description:
None
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