Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Interventions
Product Name: RITUXIMAB
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: RITUXIMAB
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Conce
Sponsors
GEL/TAMO (Cooperative Spanish Group of Lymphoma/Autologous bone marrow transplant).
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. folicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, hystologically confirmed with CD20+ 2. aged between 18 and 65 years. Pacients aged from 65 to 70 years can be included according to the investigator's criteria regarding the patients' global health status and the absence of excluding comorbility. 3. IPI adjusted to the age over 1 or a-IPI and beta2-microbloguline equal or higher than 3 mg/dl 3. Punctuation in the ECOG grade from 0 to 4 4. Life expectancy over 12 weeks 5. Writen informed consent form 6. New diagnosed patient without any previous treatment 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Existence of severe cardiac, pulmonar, neurologic, psiquiatric and metabolic diseases not caused by the lymphoma. 2. uncontrolled high blood pressure (diastolic pressure in rest > 115 mmHg) 3. Altered hepactic function (bilirrubine or AST/ALT superior or equal at 2 times the superior limit of normality) or renal (cratinine equal or superior at 1.5 times the superior limit of normality) not caused by the lymphoma. 4. other malignant neoplasies along the past 5 years, except skin tumours, excluded melanoma or carcinoma in situ of cervix 5. patients positive for HIV 6. patients with transformed folicular lymphoma 7. pregnant women or in nursing; women of childbearing age who do not use an adecuate contraceptive method before being included in the study 8. ventricular ejection fraction inferior to 50% 9. patients with severe psiquiatric diseases which can interfere with their ability for understanding the study (including alcoholism or drug addiction)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The principal end point is the valoration of the event free survival (EFS) three years later;Main Objective: To evaluate the event free survival (being event definite as death caused by any event, relapse or disease progression) at three years in patients with DLBCL (REAL/OMS) classification with IPI adjusted to the age >1 or a-IPI=1 and a high Betha2 microglobulin up to or equal 3mg/dl: In patients with positive PET after three cycles of R-MegaCHOP and early rescue treatment con R-IFE + TAPH In patients with negative PET after three cycles of chemotherapy treated with R-MegaCHOP followed by three cycles of R-MegaCHOP without TAPH.;Secondary Objective: -evaluate the overall survival after three years. -determine the rate of global responses and complete remisions, uncertain and partial. -determine the duration of the complete response after the treatment termination. -carry out an exploratoy follow up of the event free survival and the overall survival at 5 years. -evaluate the treatment toxicity according CTC criteria (version 3.0) of the National Cancer Institute (NCI). -asses the role of PET in the disease stage and response evaluation compared to CAT. -identify the predictable reponse factors after 6 cycles of treatment with R-MegaCHOP administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH in patients with DLBCL of severe prognosis. -evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment and/or R-IFE in reference with delays with the cycles administration and reductions of the chemotherapy dose (planned dose administrated in the planned term). | — |
Countries
Spain
Outcome results
None listed