| Titre |
A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| Protocole ID |
POLARGO |
| ClinicalTrials.gov ID |
NCT04182204 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase III |
| Stade |
Récidivant/réfractaire (2ième ligne de traitement et plus) |
| Type étude |
Clinique |
| Médicament |
Polatuzumab védotine en association avec R-GEMOX versus R-GEMOX seul |
| Institution |
CIUSSS DE LA MAURICIE-ET-DU-CENTRE-DU-QUEBEC
 CHAUR
1991 Boulevard du Carmel, Trois-Rivières, QC, G8Z 3R9
|
| Ville |
Trois-Rivières |
| Investigateur(trice) principal(e) |
Dr Jean-Sébastien Aucoin
|
| Coordonnateur(trice) |
Marie-Ève Caron
819-697-3333 poste 63238
|
| Statut |
 Actif en recrutement |
| Date d'activation |
12-04-2022 |
| Critètes d'éligibilité |
- Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL
- Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that progressed during therapy or progressed within 6 months (< 6 months) of prior therapy)
- At least one (≥ 1) line of prior systemic therapy:
- Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; chemotherapy followed by consolidative autologous HSCT will be counted as one line of therapy
- Patients may have undergone allogeneic HSCT prior to recruitment, so long as they are off all immunosuppressive therapy and have no active GVHD; chemotherapy followed by allogeneic HSCT will be counted as one line of therapy
- Local therapies (e.g., radiotherapy) will not be considered as lines of treatment
- At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Adequate hematological function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
|
| Critètes d'exclusion |
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Contraindication to rituximab, gemcitabine or oxaliplatin
- Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0
- Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks
- Planned autologous or allogenic stem cell transplantation at time of recruitment
- Primary or secondary central nervous system (CNS) lymphoma
- Richter's transformation or prior CLL
- Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
- Vaccination with a live vaccine within 4 weeks prior to treatment
- Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
- Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
|
Groupe d'étude en oncologie du Québec