None listed
Conditions
Interventions
Trade Name: GAZYVARO
Product Name: obinutuzumab
Product Code: GA101
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: GA101
CAS Number: 949142-50-1
Other descriptive name: OBINUTUZUMAB
C
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients OR - patients with either histologically documented CD20-positive Diffuse large-cell lymphoma (including transformations of low-grade lymphoma into DLBCL) or follicular lymphoma CD20+ grade 3b, or primary cutaneous DLBCL leg type, or primary mediastinal (thymic) large B-cell lymphoma, or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, or unclassifiable B-cell lymphoma with features intermediate between DLBCL and Hodgkin (WHO classification) OR - Relapsed/refractory indolent lymphoma (marginal zone (MZL) or lymphocytic lymphoma (LL) or measurable mucosa-associated lymphoid tissue (MALT) lymphoma) - Relapsed/refractory NHL after =1 prior R-containing regimen with no curative option - Aged 18 years or more with no upper age limit - ECOG performance status 0, 1 or 2 - Bi-dimensionally measurable disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan, or PET scan without IV contrast at diagnosis with at least one hypermetabolic lesion - Life expectancy = 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: - indolent lymphoma, waldenström macroglobulinemia, unmeasurable MALT lymphoma, and Mantle Cell Lymphoma (MCL) lymphoma - known CD20 negative status at last biopsy done (Biopsy at relapse/progression is mandatory) - central nervous system or meningeal involvement by lymphoma - prior history of Progressive Multifocal Leukoencephalopathy (PML) - documented infection with HIV - active hepatitis B OR positive serology to hepatitis B - active hepatitis C infection - known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) - active immune-related disease criteria - LVEF 2.0 mg/dL (34 µmol/L), except if disease related or in case of Gilbert syndrome - Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of 1.5 x ULN - Prior history of malignancies other than lymphoma unless the subject has been free of the disease for = 3 years. Excepted non-melanoma skin tumors or any surgically removed stage 0 (in situ) carcinoma - contraindication to any drug contained in the study treatment regimen - previous treatment with obinutuzumab, atezolizumab or venetoclax - use of any standard or experimental anti-cancer drug therapy within 28 days prior to first administration of study drug - use of warfarin prior to first administration of study drug and throughout all treatment period - corticosteroids within 4 weeks prior to first administration of study drug, unless administered at a cumulated dose equivalent to = 3.5mg/kg (within these 4 weeks). - use of the following agents prior to first administration of study drug: - strong and moderate CYP3A inhibitors (including grapefruit juice) - strong and moderate CYP3A inducers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the anti-lymphoma activity of an anti-PD-L1 (atezolizumab) associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts: - relapsed/refractory follicular lymphoma (FL) patients - relapsed/refractory aggressive (DLBCL) lymphoma patients - relapsed/refractory other indolent lymphoma patients ;Secondary Objective: - to evaluate safety and tolerability of atezolizumab+ venetoclax+obinutuzumab for relapsed/refractory B-cell lymphomas - to assess the efficacy of the combination of obinutuzumab+ atezolizumab+venetoclax ;Primary end point(s): Overall Metabolic Response Rate (OMRR) according to Lugano 2014 response criteria;Timepoint(s) of evaluation of this end point: end of induction = 8 cycles of obinutuzumab, atezolizumab and venetoclax or at premature treatment discontinuation (if patient did not complete 8 cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - number of SAE - Progression Free Survival (PFS) - Overall Survival (OS) - Duration of Response (DoR) - Overall Metabolic Response Rate (OMRR) - Best Response (BR) - Long-term safety (second cancer, immune-related disease) ;Timepoint(s) of evaluation of this end point: - number of SAE = 28 days after end of treatment (EOT) - Progression Free Survival (PFS) = end of study - Overall Survival (OS) = end of study - Duration of Response (DoR) = end of study - Overall Metabolic Response Rate (OMRR) - after 4 and 8 cycles according to LYRIC (LYmphoma Response to Immunomodulatory therapy Criteria) - after 4 cycles (M3) and at EOT (M18) according to Lugano 2014 response criteria - Best Response (BR) = end of study - Long-term safety (second cancer, immune-related disease) = end of study | — |
Countries
France
Contacts
Public ContactProject Management - J.Assémat
LYSARC
Outcome results
None listed