| Titre |
A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma |
| Protocole ID |
GO40515 |
| ClinicalTrials.gov ID |
NCT03677141 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase I-II |
| Type étude |
Traitement |
| Médicament |
Mosunetuzumab avec CHOP ou CHP-Polatuzumab Vedotine |
| 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) |
Aline Khayat
514-340-8222
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
Inclusion Criteria for Phase Ib and Phase II Portions
- At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest diameter
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Adequate hematologic function
Inclusion Criteria for Phase Ib Portion
- Participants must also meet the following criteria for study entry in the Phase Ib portion:
- Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen
- Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy
- Treatment with at least one prior CD20-directed therapy
- Group B only: no prior treatment with polatuzumab vedotin
Inclusion Criteria for Phase II Portion
- Participants must also meet the following criteria for study entry in the Phase II portion:
- Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
- International Prognostic Index (IPI) score of 2−5
|
| Critètes d'exclusion |
- Prior treatment with mosunetuzumab
- Prior allogenic stem-cell transplant
- Current Grade >1 peripheral neuropathy
- Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
- Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
- Prior solid organ transplantation
- History of autoimmune disease
- Current or past history of central nervous system (CNS) lymphoma
- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Significant cardiovascular disease or pulmonary disease
- Clinically significant history of liver disease
- Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis
Exclusion Criteria for Phase Ib Portion
- Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion:
- Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1
- Prior treatment with radiotherapy within 2 weeks prior to C1D1
- Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia)
- Prior treatment with >250 mg/m^2 doxorubicin (or equivalent anthracycline dose)
Exclusion Criteria for Phase II Portion
- Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion:
- Participants with transformed lymphoma
- Prior therapy for B-cell NHL
|
Groupe d'étude en oncologie du Québec