Metronomic Chemotherapy in Elderly Non-fit Patients With Aggressive B-Cell Lymphomas

• Status: Completed
• Trial end date: 2020-11-18
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study of metronomic chemotherapy in elderly non-fit patients (>65 years) with aggressive B-Cell lymphomas

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

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Cyclophosphamide; Etoposide; Etoposide phosphate; Prednisone; Rituximab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of aggressive Non-Hodgkin Lymphomas (NHLs) including:

• LBCL1

• DLBCL;

• Grade IIIb follicular lymphoma;

• BL1;

• B-Cell unclassifiable lymphomas with features intermediate between DLBCL and BL or between DLBCL and Hodgkin's lymphoma (HL)35;

• High grade B-cell lymphomas1

• Age >65 years

• Unfit or frail patients (the latest defined, for the purpose of this study, as those who have a maximum of 1 frail factor) according to the multidimensional geriatric evaluation model of the elderly platform of the FIL, who relapsed/progressed after one or maximum two previous lines of treatment or

• "Super-frail" elderly patients at disease onset: eligible super-frail patients are defined, for the purpose of this study, as those who have a maximum of 2 frail factors, according to the CGA adopted in the elderly platform of the FIL, among those below listed:

• ADL ≤ 4;

• IADL ≤ 5;

• Age ≥ 80 years;

• 1 CIRS grade 3 or >8 CIRS grade 2.

• Ann Arbor stage I bulky to IV

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

• Life expectancy >1-2 months.

• Adequate renal function (creatinine ≤ 2 mg/dl, unless secondary to lymphoma).

• Adequate liver function (bilirubin ≤ 2 mg/dl, unless secondary to lymphoma).

• Absolute neutrophil count (ANC) ≥1500 cells/mmc and platelets ≥ 50,000 cells/mmc, haemoglobin ≥ 9 gr/dl, unless cytopenia is related to bone marrow involvement by lymphoma.

• Availability of adequate care by family members or other caregivers.

• Written informed consent signature.

• Male Subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 3 months following the end or the discontinuation from the study treatment even if he has undergone a successful vasectomy.

Exclusion Criteria:

• Patients who received more than two previous chemotherapy lines.

• Relapsed/refractory patients with fit profile.

• Fit, unfit, and frail patients at disease onset.

• Malabsorption syndrome or other diseases that affect the ability to swallow oral therapy.

• Concomitant malignancy requiring treatment (except non-melanoma skin cancers and in situ carcinoma of the uterine cervix).

• Presence of opportunistic infections in place.

• Seropositive for or active viral infection with hepatitis B virus (HBV):

1. HBsAg positive;

2. HBsAg negative, HBcAb positive with detectable viral DNA (Subjects who are HBsAg negative, HBcAb positive, but viral DNA negative are eligible.

• Seropositive and active infection for hepatitis C virus (subjects who are HCV-RNA negative are eligible).

• Known seropositive for or active viral infection with human immunodeficiency virus (HIV).

• Impossibility to give written informed consent.