Patient with diffuse large B cell lymphoma (DLBCL) with low risk profile according to age-adjusted IPI (0 with bulky or 1) MedDRA version: 17.1 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas System Organ Class: 100000004851
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CYCLOPHOSPHAMIDE MONOHYDRATE
CAS Number: 6055-19-2
Current Sponsor code: NA
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Pharma
Sponsors
Fondazione Italiana Linfomi ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-80 years Patients aged > 70 years with FIT profile according to VGM Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma aaIPI=1 +/- bulky and aaIPI=0 with bulky (>7.5 cm) ECOG-PS 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: CD20 negative B-cell lymphoma; Lymphoblastic lymphoma or Burkitt’s lymphoma; Primary Mediastinal B-cell Lymphoma; Grade I, II, IIIa Follicular Lymphoma, Lymphocytic/Lymphoplasmacytic, Marginal, Mantle Lymphoma; T cell Lymphoma (any histotype); Patients aged > 80 years and 3 if not related to lymphoma; Patient already treated with chemotherapy, RT, immunotherapy (with the exception of therapies specified in the study protocol); Creatinine >1.4 mg/dl or creatinine clearance 2.5 times normal limit, unless the alteration is due to lymphoma; Clinically significant cardiopathies or cardiovascular disease (e.g. uncontrolled hypertension, uncontrolled multifocal cardiac arrhythmias); Ventricular ejection fraction < 50%; Pulmonary pathologies (e.g. BPCO, pulmonary fibrosis, TBC etc); Concurrent thrombohemolytic disease; HIV positivity; Positive serology for HBV (HBsAg+) and HCV positivity in presence of replication marks; CNS localization disease; Malignancy during last 3 years, except from carcinoma in situ of the cervix, basal cell skin carcinoma or early stage prostate cancer or DCIS (good prognosis) treated only with surgery; Inability of the patient to give her/his informed consent; Drug addiction or alcoholism; Pregnancy or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate if a chemoimmunotherapy R-CHOP-14 or R-CHOP-21 +/- consolidation RT on positive PET-TC residual mass improves the prognosis in terms of 2years PFS in comparison to an historical population control treated with R-CHOP and RT on bulky disease independently of PET-TC evaluation. ;Secondary Objective: To evaluate the efficacy of a consolidation RT involved-field on single residual PET-positive area after 6 R-CHOP-14 or R-CHOP-21 cycles in terms of overall response rate (ORR = complete + partial remission: CR +PR) improvement according to standard international response criteria (Cheson 2007); To evaluate the ORR after 4 and 6 R-CHOP-14 or R-CHOP-21 cycles; To explore the predictive role of the early PET after 2 R-CHOP-14 or R-CHOP-21 cycles in terms of 2-year PFS (descriptive analysis based on available data). ;Primary end point(s): PFS, defined as no response after the first 4 cycles or 6 cycles of immunochemotherapy or progression disease after consolidation RT or at any time of therapy, relapse or death from any cause. The PFS includes all patients and its duration is calculated from the date of initiation of therapy to the date of occurrence of any of the events or date of last follow-up, in the absence of such events.;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): OS, defining the event as death from any cause. OS includes all patients and the duration is calculated from the initiation of therapy to the date of death or of last follow up. ;Timepoint(s) of evaluation of this end point: 4 years | — |
Countries
Italy
Contacts
Public ContactSegreteria Scientifica
Fondazione Italiana Linfomi ONLUS
Outcome results
None listed