Informations générales (source: ClinicalTrials.gov)
A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma (GLOBRYTE)
Interventional
Phase 3
Hoffmann-La Roche (Voir sur ClinicalTrials)
octobre 2023
décembre 2026
10 octobre 2024
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared
with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide
with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma
(MCL).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:26 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital Claude Huriez; Hematologie - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Eloi; Hematologie Oncologie Medicale - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale. - 92210 - St Cloud - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Life expectancy at least 12 weeks
- Histologically-confirmed MCL, with documentation of either overexpression of cyclin
D1 or the presence of t(11:14)
- Relapsed (disease progression after the last treatment regimen) or refractory
(failure to achieve a partial or complete response from the last treatment regimen)
disease
- At least 1 line of prior systemic therapy including a BTK inhibitor and additional
systemic therapy option
- Confirmed availability of tumor tissue, unless deemed unsafe per investigator
assessment
- At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion,
or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on
CT scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Negative HIV test at screening
- Adequate hematological function
- Life expectancy at least 12 weeks
- Histologically-confirmed MCL, with documentation of either overexpression of cyclin
D1 or the presence of t(11:14)
- Relapsed (disease progression after the last treatment regimen) or refractory
(failure to achieve a partial or complete response from the last treatment regimen)
disease
- At least 1 line of prior systemic therapy including a BTK inhibitor and additional
systemic therapy option
- Confirmed availability of tumor tissue, unless deemed unsafe per investigator
assessment
- At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion,
or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on
CT scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Negative HIV test at screening
- Adequate hematological function
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or
within 3 months after the final dose of tocilizumab, 2 months after the final dose
of glofitamab, whichever is longer
- Leukemic, non-nodal MCL
- 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 obinutuzumab or rituximab, and either bendamustine or
lenalidomide
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20
and CD3
- Prior treatment with CAR-T cell therapy
- Treatment with systemic therapy or BTK inhibitors, or any investigational agent for
the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is
shorter) prior to first study treatment
- Primary or secondary CNS lymphoma at the time of recruitment or history of CNS
lymphoma
- Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or
neurodegenerative disease
- History of other malignancy that could affect compliance with the protocol or
interpretation of results
- Significant or extensive cardiovascular disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
at study enrollment or any major episode of infection within 4 weeks prior to the
first study treatment
- Suspected or latent tuberculosis
- Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Known or suspected chronic active Epstein-Barr viral infection (EBV)
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy (PML)
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or
better
- Administration of a live, attenuated vaccine within 4 weeks before first study
treatment administration or anticipation that such a live, attenuated vaccine will
be required during the study
- Prior solid organ transplantation or allogenic stem cell transplant
- Eligibility for stem cell transplantation (SCT)
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications within 2 weeks or five
half-lives (whichever is shorter) prior to the first dose of study treatment
- Corticosteroid therapy within 2 weeks prior to first dose of study treatment
- Recent major surgery (within 4 weeks before the first study treatment) other than
for diagnosis
- Clinically significant history of cirrhotic liver disease