Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414148
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-29
Brief Title:
MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
Peter MacCallum Cancer Centre Australia
Study Overview
Official Title:
A Phase II Open-Label Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma EpLCART
Status:
RECRUITING
Status Verified Date:
2024-08
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:
EpLCART
Brief Summary:
This is a Phase II open-label two-arm randomised non-comparative multi-centre study to evaluate the efficacy of Epcor-only Epcoritamab alone or Epcor-R2 Epcoritamab lenalidomide and rituximab as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease MRD positive as determined by a Circulating Tumour DNA ctDNA assay
Detailed Description:
Patients who have received CAR T-cell therapy for RelapsedRefractory Large B-Cell Lymphoma are in Complete Metabolic Response CMR or Partial Metabolic Response PMR and MRD positive post CAR T-cell infusion are potentially eligible Once these patients have provided their consent they will enter the screening phase All events of Cytokine Release Syndrome CRS Haemophagocytic Lymphohistiocytosis HLHMacrophage Activation Syndrome MAS Immune-Effector Cell Associated Neurologic Syndrome ICANS or infection must have completely resolved Additionally patients must have adequate organ and haematological function and an ECOG performance status of up to 2
Patients deemed eligible for the study will be randomised to receive Epcor-only Arm A or Epcor-R2 Arm B for 6 cycles The primary endpoint is CMR by Lugano 2014 criteria at month 12 post CAR T-cell infusion
Patients will undergo an interim response assessment after 2 cycles of treatment Patients that complete the full 6 cycles of treatment or that discontinue treatment for any reason will have an End of Treatment visit and a Safety Follow-up visit at 60 days after Day 1 of Cycle 6 Patients with non-Progressive Disease PD then enter the follow-up phase of the study where they will undergo response assessments at month 12 15 18 and 24 after CAR T-cell infusion Patients with PD at any time will complete a Progression visit Patients that have completed the month 24 Follow-up visit or that they have progressed will be followed for survival and new anti-lymphoma therapy only All patients will be followed for 2 years after the last patient randomised received the CAR T-cell infusion
Patients deemed eligible for the study will be randomised to receive Epcor-only Arm A or Epcor-R2 Arm B for 6 cycles The primary endpoint is CMR by Lugano 2014 criteria at month 12 post CAR T-cell infusion
Patients will undergo an interim response assessment after 2 cycles of treatment Patients that complete the full 6 cycles of treatment or that discontinue treatment for any reason will have an End of Treatment visit and a Safety Follow-up visit at 60 days after Day 1 of Cycle 6 Patients with non-Progressive Disease PD then enter the follow-up phase of the study where they will undergo response assessments at month 12 15 18 and 24 after CAR T-cell infusion Patients with PD at any time will complete a Progression visit Patients that have completed the month 24 Follow-up visit or that they have progressed will be followed for survival and new anti-lymphoma therapy only All patients will be followed for 2 years after the last patient randomised received the CAR T-cell infusion
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