| Titre |
A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma |
| Protocole ID |
GCT3013-05 |
| ClinicalTrials.gov ID |
NCT04628494 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase III |
| Stade |
Lymphome diffus à grandes cellules B |
| Type étude |
Clinique |
| Médicament |
Epcoritamab versus une chimiothérapie au choix de l'investigateur (R-GemOx ou BR) |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Jean-François Larouche
|
| Coordonnateur(trice) |
Philippe Nadeau
418-649-0252 poste 63115
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis
-
One of the confirmed histologies below with CD20-positivity:
- DLBCL, NOS, including de novo or histologically transformed from FL
- "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
- FL Grade 3B
- ECOG PS score of 0-2
- Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
- Patients must have detectable disease by PET scan and measurable by CT scan or MRI
- Acceptable renal and liver function
- Life expectancy >2 months on SOC treatment
|
| Critètes d'exclusion |
- Primary CNS tumor or known CNS involvement
- Any prior therapy with a bispecific antibody targeting CD3 and CD20
- Major surgery within 4 weeks prior to randomization
- Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
- Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
- ASCT within 100 days of randomization
- Treatment with CAR-T therapy within 100 days prior to randomization
- Seizure disorder requiring anti-epileptic therapy
- Clinically significant cardiac disease,
|
Groupe d'étude en oncologie du Québec