| Titre |
Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma |
| Protocole ID |
TRPH-222-100 |
| ClinicalTrials.gov ID |
NCT03682796 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase I |
| Stade |
Lymphome diffus à grandes cellules B |
| Type étude |
Traitement |
| Médicament |
TRPH-222 |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Sarit Assouline
|
| Coordonnateur(trice) |
Chadi Zakaria
514-340-8222 poste 28326
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Age ≥ 18 years at the time of signing the informed consent
- Histologically confirmed (2016 WHO lymphoma classification) B-cell NHL that is DLBCL, FL (including transformed FL), MZL, or MCL
- Relapsed and/or refractory NHL requiring systemic therapy and have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments that are known to be potentially curative. Subjects must not be current candidates for HSCT. Participants who refuse standard treatments may also be considered provided that documentation is provided that the subject has been made aware of all therapeutic options
- Eastern Cooperative Oncology Group (ECOG) status 0-2
|
| Critètes d'exclusion |
- Presence of a leukemic phase of the lymphoma
- "Double hit" or "triple hit" germinal center B cell lymphoma
- Previous solid organ allograft (except for corneal transplant)
- Peripheral neuropathy > NCI-CTCAE Grade 1
- Significant organ dysfunction that would preclude study participation
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias
- Any other serious active disease or co-morbid medical condition, according to the Investigator's decision or Medical Monitor, that will substantially increase the risk associated with the subject's participation in the study
|
Groupe d'étude en oncologie du Québec