Treatment with R-MegaCHOP and early rescue with R-IFE and autologous stem cells transplant (ASCT) according response measured by positron emission tomography (PET) in patients with diffuse large B-cell lymphoma (DLBCL) with severe prognosis. - GEL/TAMO-2006

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)

Registration Number: EUCTR2006-005254-68-ES

Lead Sponsor: GEL/TAMO (Cooperative Spanish Group of Lymphoma/Autologous bone marrow transplant).

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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)