Dose Densified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk (aaIPI≥ 2) Diffuse Large B-Cell Lymphoma
Inclusion Criteria:
- Age ≥ 18 - < 65 years. Histologically confirmed CD20+ diffuse large B-cell lymphoma
(DLBCL) based on WHO 2008 Lymphoma Classification
- Follicular lymphomas (FLs) grade 3b is allowed
Patients in at least stage II with age adjusted international prognostic score (IPI score)
of 2 or 3:
- Stage III /IV and elevated LDH
- Stage III/IV and WHO performance status 2 - 3
- Stage II and elevated LDH and WHO performance status 2 - 3 And/or patients with
- More than one extranodal site
- Testicular lymphoma, stage IIE and higher
- Paranasal sinus and orbital lymphoma with destruction of bone
- Large cell infiltration of the bone marrow
Exclusion Criteria:
- Severe cardiac disease: cardiac function grade 3-4
- Impaired liver, renal or other organ function not caused by lymphoma, which will
interfere with the treatment schedule
- Pregnancy/lactation
- 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
- Patients with other severe medical problems and with an expected short survival for
non-lymphoma reasons
- Known HIV positivity
- Uncontrolled infectious disease, including meningeal infection
- Active cancer except basal cell carcinoma and cervical carcinoma in situ during the
last five years
- Earlier treatment containing anthracyclins
- Psychiatric or mental disorder which make the patient unable to give an informed
consent and/or adhere to the protocol
- CNS disease as diagnosed by MRI or cerebrospinal fluid (CSF) cytology. Positive CSF
flow cytometry below diagnostic threshold level by cytology is allowed
- Pleural or peritoneal fluid that cannot be drained safely
- Hypersensitivity to the active substance or any of the other ingredients
- Patients participating in other clinical studies, unless followed for survival