Metronomic chemotherapy in elderly non-fit patients with aggressive B-Cell lymphomas. Phase II study
- Conditions
- Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]B-Cell lymphomasMedDRA version: 21.0Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864
- Registration Number
- EUCTR2016-003703-62-IT
- Lead Sponsor
- FONDAZIONE ITALIANA LINFOMI ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
• 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method