Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508658
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously IV Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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:
EPCORE DLBCL-4
Brief Summary:
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells a white blood cell responsible for fighting infections This study will assess how safe and effective epcoritamab plus lenalidomide E-Len is compared to rituximab plus gemcitabine and oxaliplatin R-GemOx in treating adult participants with relapsed or refractory RR Diffuse Large B-Cell Lymphoma DLBCL Adverse events and change in disease condition will be assessed
Epcoritamab is an investigational drug being developed for the treatment of DLBCL Study doctors put the participants in 1 of 2 groups called treatment arms Each group receives a different treatment Around 320 adult participants with RR DLBCL will be enrolled in approximately 165 sites across the world
Participants in arm A will receive subcutaneous SC injections of epcoritamab plus oral lenalidomide capsules E-Len for up to 12 cycles each cycle is 28 days Participants in arm B will receive intrav IV infused R-GemOx for up to 4 cycles each cycle is 28 days
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Epcoritamab is an investigational drug being developed for the treatment of DLBCL Study doctors put the participants in 1 of 2 groups called treatment arms Each group receives a different treatment Around 320 adult participants with RR DLBCL will be enrolled in approximately 165 sites across the world
Participants in arm A will receive subcutaneous SC injections of epcoritamab plus oral lenalidomide capsules E-Len for up to 12 cycles each cycle is 28 days Participants in arm B will receive intrav IV infused R-GemOx for up to 4 cycles each cycle is 28 days
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
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