Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191744
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-12-20
Brief Title:
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide R2 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma
Sponsor:
Genmab
Organization:
Genmab
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab Rituximab and Lenalidomide R2 Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma EPCOREFL-2
Status:
RECRUITING
Status Verified Date:
2024-10
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:
EPCOREFL-2
Brief Summary:
Follicular lymphoma FL is the second most common B-cell cancer and the most common type of cancer of lymphocytes Unfortunately this disease is incurable with conventional treatment and the disease recurs in almost all patients This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab R2 in treating adult participants with previously untreated FL Adverse events and change in disease condition will be assessed
Epcoritamab is an investigational drug being developed for the treatment of FL Study doctors put the participants in 1 of 4 groups called treatment arms Each group receives a different treatment Around 1080 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world
Participants will receive R2 intravenous IV infusion of rituximab R and oral capsules of lenalidomide alone or in combination with subcutaneous injections of epcoritamab Participants may also receive investigators choice chemoimmunotherapy CIT IV infusion of obinutuzumab G and IV injections of cyclophosphamide IV injections of doxorubicin IV injections of vincristine oral tablets of prednisone CHOP G-CHOP R-CHOP or G and IV infusion of bendamustine Benda G-BendaR-Benda The total treatment duration will be 120 weeks
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 FL Study doctors put the participants in 1 of 4 groups called treatment arms Each group receives a different treatment Around 1080 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world
Participants will receive R2 intravenous IV infusion of rituximab R and oral capsules of lenalidomide alone or in combination with subcutaneous injections of epcoritamab Participants may also receive investigators choice chemoimmunotherapy CIT IV infusion of obinutuzumab G and IV injections of cyclophosphamide IV injections of doxorubicin IV injections of vincristine oral tablets of prednisone CHOP G-CHOP R-CHOP or G and IV infusion of bendamustine Benda G-BendaR-Benda The total treatment duration will be 120 weeks
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?:
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506906-38-00 | OTHER | EU CT | None |