CHOEP-14 + rituximab with CNS prophylaxis in patients less than 65 years with Diffuse Large B-Cell Lymphoma/Follicular Lymphoma grade III, stage II-IV with risk factors (age adjusted IPI) = 2.A phase II study (NLG-LBC-04)

Conditions: 18-64 year old patients having primary diffuse large B-cell lymphoma (DLBCL) with risk factors (age adjusted IPI=2), or follicular lymphoma grade III

Registration Number: EUCTR2004-003075-37-FI

Lead Sponsor: ordic Lymphoma Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Age = 18 - < 65 years.
2. Histology verified according to the WHO classification and with CD20 positivity
-Diffuse large B-cell lymphomas with subgroups
-Follicular lymphomas grade III
3. Patients in at least stage II with age adjusted IPI score of 2 or 3:
Stage III /IV and elevated LDH and/or WHO performance status 2 - 3
Stage II and elevated LDH and WHO performance status 2 - 3.
4. Previously untreated.
5. Performance status < 4 (Appendix 2).
6. Written informed consent
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Severe cardiac disease (i.e. heart failure, Cardiac function grade III - IV or Left Ventricular Ejection Fraction (LVEF) < 45%.
2. Impaired liver, renal or other organ function not caused by lymphoma and which will interfere with the treatment schedule.
3. Pregnancy.
4. Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment.
5. Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons.
6. Known HIV positivity.
7. Present or previous cancer except basal cell carcinoma and cervical carcinoma in situ.
8. Uncontrolled infectious disease.
9. Psychiatric or mental disorder which make the patient unable to give an informed consent
and/or adhere to the protocol.