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)

• Conditions: Patient with diffuse large B cell lymphoma (DLBCL) with low risk profile according to age-adjusted IPI (0 with bulky or 1); MedDRA version: 17.1Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-003769-14-IT
• Lead Sponsor: Fondazione Italiana Linfomi ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 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

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 < 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified