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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 December 2021
• Main ID: NCT03161054
• Date of registration: 18/05/2017
• Prospective Registration: Yes
• Primary sponsor: Fondazione Italiana Linfomi ONLUS
• Public title: Metronomic Chemotherapy in Elderly Non-fit Patients With Aggressive B-Cell Lymphomas
• Scientific title: A Phase II Study of Metronomic Chemotherapy in Elderly Non-fit Patients (>65 Years) With Aggressive B-Cell Lymphomas
• Date of first enrolment: September 12, 2017
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03161054
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Francesco Merli, MD
• Affiliation: AUSL - IRCCS Arcispedale Santa Maria Nuova viale Risorgimento 80 42123, Reggio Emilia

Key inclusion & exclusion 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.



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aggressive Non-Hodgkin Lymphoma

Intervention(s)

Drug: Rituximab

Drug: Etoposide

Drug: Prednisone

Drug: Cyclophosphamide

Drug: Vinorelbine

Primary Outcome(s)

Complete Remission Rate (CRR) [Time Frame: 30 months]

Incidence of adverse events [Time Frame: 30 months]

Secondary Outcome(s)

Clinical Benefit [Time Frame: 30 months]

Disease Free Survival (DFS) [Time Frame: 36]

Overall Survival (OS) [Time Frame: 36]

Event Free Survival (EFS) [Time Frame: 36]

Overall response rate (ORR) [Time Frame: 30 months]

Patient-Reported Outcome (PRO) [Time Frame: 36]

Progression Free Survival (PFS) [Time Frame: 36]

Secondary ID(s)

FIL_DEVEC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors