GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma
Condition: CD20 Positive Diffuse Large B-cell Lymphoma; Elderly Unfit Patients
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Ga101
Intervention MeSH terms: Obinutuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell
      non-Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade
             III B lymphoma, according to WHO (World Health Organization) classification (local
             pathologist)

          2. Age ≥ 65 years

          3. No previous treatment

          4. CGA assessment (Comprehensive Geriatric Assessment) performed before starting
             treatment

          5. Unfit patients defined as follows:

             Age > 80 years with Fit profile, i.e. ADL (Activity of Daily Living) =6 residual
             functions IADL (Instrumental Activity of Daily Living) =8 residual functions CIRS
             (Cumulative Illness Rating Scale): no comorbidity of grade 3-4 and <5 of grade 2 or
             Age < 80 with Unfit profile, i.e ADL(Activity of Daily Living) > 5 residual functions
             IADL (Instrumental Activity of Daily Living) > 6 residual functions CIRS (Cumulative
             Illness Rating Scale): no comorbidity of grade 3-4 and 5-8 co-morbidities of grade 2

          6. Ann Arbor Stage I with bulky, II-IV

          7. At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest
             dimension on CT scan

          8. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2

          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 (Left Ventricular Ejection Fraction) >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

        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 (Cyclophosphamide,
             Doxorubicin, Vincristine, Prednisone), 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 (Diffuse Large B Cell Lymphoma), with the exception of nodal
             biopsy or local irradiation

          7. Previous exposure to cytotoxic agents

          8. Suspect or clinical evidence of CNS (Central Nervous System) involvement by lymphoma

          9. HBsAg (Hepatitis B surface antigen), HCV (Hepatitis C Virus) or HIV (Human
             Immunodeficiency Virus) positivity; isolated HBcAb (Hepatitis B surface antibody)
             positivity is accepted only with concomitant treatment with Lamivudine

         10. AST /ALT (Aspartate Aminotransferase/Alanine Aminotransferase)> 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