Cd20 positive diffuse large B-cell lymphoma in unfit elderly patients
Conditions
Interventions
Trade Name: GAZYVARO
Product Name: GAZYVARO
Product Code: GA101
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 949142-50-1
Current Sponsor code: GA101
Other descriptive name: O
Sponsors
Fondazione Italiana Linfomi ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade IIIB lymphoma, according to WHO classification (local pathologist) 2) Age = 65 years 3) No previous treatment 4) CGA assessment performed before starting treatment 5) UNFIT patients defined as follows (see Appendices A-D): Age > 80 years with FIT profile, i.e. ADL =6 residual functions IADL=8 residual functions CIRS: no comorbidity of grade 3-4 and 5 residual functions IADL > 6 residual functions CIRS: no comorbidity of grade 3-4 and 5-8 co-morbidities of grade 2 6) Ann Arbor Stage I with bulky, II-IV (Appendix E) 7) At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan 8) ECOG performance status of 0, 1, or 2 (Appendix G) 9) Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows: Hemoglobin = 10 g/dL Absolute neutrophil count = 1.5 x 109/L Platelet count = 100 x 109/L 10) LVEF >50% 11) Ability and willingness to comply with the study protocol procedure 12) Life expectancy > 6 months 13) Accessibility of patient for treatment and follow up 14) Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: 1) History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products 2) Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines 3) History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer 4) Stage I without bulky 5) Patients with transformed lymphoma 6) Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation 7) Previous exposure to cytotoxic agents 8) Suspect or clinical evidence of CNS involvement by lymphoma 9) HBsAg, HCV or HIV positivity; isolated HBcAb positivity is accepted only with concomitant treatment with Lamivudine 10) AST /ALT > twice upper the normal range; bilirubin > twice upper the normal range; serum creatinine > 2.5 mg /dl (unless these abnormalities were related to the lymphoma) 11) Evidence of any severe active acute or chronic infection 12) Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the activity of GA101-miniCHOP regimen in terms of complete response rate (CRR);Timepoint(s) of evaluation of this end point: 36 months from first patient in ;Secondary Objective: • To evaluate the safety and tolerability of GA101 miniCHOP regiment in terms of adverse events • Partial and Overall Response Rate: PR and ORR (CR+PR) • Overall Survival (OS) • Progression Free Survival (PFS) • Dynamics of Comprehensive Geriatric Assessment (CGA) • Dynamics of Quality of Life (QoL) questionnaires ;Primary end point(s): • Complete Response Rate after 10 infusions of GA101 and 6 cycles of miniCHOP. The response rate to therapy will be based a central Independent Review Committee of response that will not consider the results of FDG-PET but will only use the conventional CT scan images (International Criteria, B. Cheson, JCO 1999) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Rate of Adverse Events • Partial and Overall Response Rate (PRR, ORR) • Overall Survival (OS) • Progression Free Survival (PFS) • Change in ADL, IADL and CIRS • Change in QoL (EORTC QLQ C30);Timepoint(s) of evaluation of this end point: Rate of Adverse Events, Partial and Overall Response Rate (PRR, ORR), Change in ADL, IADL and CIRS, Change in QoL (EORTC QLQ C30): 36 months from first patient in; Overall Survival (OS) Progression Free Survival (PFS): from 60 months from first patient in | — |
Countries
Italy
Contacts
Public ContactSegreteria FIL ONLUS
Fondazione Italiana Linfomi ONLUS
Outcome results
None listed