R-CHOP-14 or R-CHOP-21 & consolidation PET–oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)

Fondazione Italiana Linfomi ONLUS0 个研究点开始时间: 2012年3月7日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•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 unless due to lymphoma
•Ventricular ejection fraction = 50%
•Biochemical, renal and hepatic tests within normal range
•Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml.
•Written informed consent
•Life-expectancy > 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

•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 < 18 years;
•Age-adjusted IPI= 0 (with no bulky disease);
•PS > 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 <60 ml/min;
•AST/ALT or Bilirubin >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.

发起方

Fondazione Italiana Linfomi ONLUS