GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma

• Status: Terminated
• Trial end date: 2017-03-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Obinutuzumab

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