B-Cell lymphomas MedDRA version: 21.0 Level: LLT Classification code 10012855 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) System Organ Class: 100000004864
Conditions
Interventions
Trade Name: PREDNISONE DOC GENERICI - "25 MG COMPRESSE" 10 COMPRESSE IN BLISTER PVC-PVDC/ALU
Product Name: Prednisone
Product Code: [IMP1]
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
C
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed diagnosis of aggressive Non-Hodgkin lymphomas (NHLs)* including: - Diffuse large B-Cell lymphoma (DLBCL); - Large B Cell Lymphomas; - Grade IIIb follicular lymphoma; - Burkitt lymphoma (Swerdlow SH et al, 2008); - High grade B-cell lymphomas (Swerdlow SH, et al. 2016); - B-Cell unclassifiable lymphomas with features intermediate between DLBCL and BL (Campo E et al, 2011) or between DLBCL and Hodgkin’s lymphoma (HL). * only for patients at disease onset or R/R with initial diagnosis of T-NHL. • 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) =1,500 cells/mmc, platelets = 50,000 cells/mmc, and hemoglobin = 9.5 gr/dL (unless cytopenia is related to 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. 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 60
Exclusion criteria
Exclusion criteria: • Patients who received more than two previous chemotherapy lines. • Stage I, who may be treated with a short course of chemotherapy and radiotherapy. • Patients with CNS involvement • Relapsed/refractory patients with fit profile. • Fit, unfit, and frail patients at disease onset. • Patients with a high fragility functional status, defined, for the purpose of this study, as with > 1 CIRS grade 3 or 1 CIRS grade 3 and >8 CIRS grade 2. • Super-Frail patients with more than 2 frail factors. • Patient with Eastern Cooperative Oncology Group (ECOG) performance status >2 • 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): a. HBsAg positive; b. 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 (HCV); 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To explore the activity of the DEVEC induction + maintenance schedule (Cyclophosphamide, Etoposide, Vinorelbine, and Prednisone +/- Rituximab) in unfit and frail patients with R/R LBCL and BL and in super-frail patients with LBCL and BL at disease onset. 2) To explore the safety of the DEVEC induction + maintenance schedule in unfit and frail patients with R/R LBCL and BL and in super-frail patients with LBCL and BL at disease onset. ;Secondary Objective: 1) To evaluate the ORR and the Clinical Benefit* evaluated at the end of induction (EOI) cycles. 2) To evaluate the investigator-assessed PFS. 3) To evaluate the Event Free Survival (EFS). 4) To evaluate the Disease Free Survival (DFS), for patients in complete response (CR) or complete response unconfirmed (CRu). 5) To evaluate the OS. 6) To assess patient-reported outcome (PRO). 7)To assess PGx and PK of DEVEC combination. 8) To investigate possible associations between biomarkers and patient outcome. *In order to define the Clinical Benefit, the condition of remission or stable disease (SD) should last at least three months. ;Primary end point(s): The primary efficacy endpoint is defined in terms of complete response (CR), including complete response unconfirmed (CRu), according to Recommendations of an International Workshop to Standardise Response Criteria for Non-Hodgkin´s Lymphomas. • The primary safety endpoint is defined as incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.;Timepoint(s) of evaluation of this end point: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the ORR and the Clinical Benefit* evaluated at the end of induction (EOI) cycles.; To evaluate the investigator-assessed Progression-Free Survival (PFS).; To evaluate the Event Free Survival (EFS); To evaluate the Overall Survival (OS).; To evaluate the Disease Free Survival (DFS), for patients in complete response (CR) or complete response unconfirmed (CRu) after induction; To assess patient-reported outcome (PRO).; PGx and PK parameters.; Serum concentrations of disease markers such as soluble CD30 receptor pharmacodynamic biomarkers.;Timepoint(s) of evaluation of this end point: 30 months; 36 months; 36 months; 36 months; 36 months; 36 months; within 3 months from the blood sample; within 3 months from the blood sample | — |
Countries
Italy
Contacts
Public ContactUffici studi FIL
Fondazione Italiana Linfomi Onlus
Outcome results
None listed