Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell Lymphoma

Inclusion Criteria:

1. Written informed consent

2. Histologically confirmed adult patients diagnosed with CD20-positive monomorphic PTLD,DLBCL irrespective of EBV association

3. Patients having undergone solid organ transplantation (heart, lung, liver, kidney,pancreas, small intestine transplantation, etc or a combination of the organtransplantations mentioned).

4. No prior treatment for PTLD, DLBCL except reduction of immunosuppression

5. At least one measurable lesion ≥ 1.5 cm in greatest transverse diameter by spiral CT

6. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.

7. Age ≥ 19

8. Adequate renal function: serum creatinine level < 2.0 mg/dL

9. Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value (or < 5 xULN in the presence of DLBCL involvement of the liver), bilirubin < 2 X upper normalvalue (or < 5 x ULN in the presence of DLBCL involvement of the liver)

10. Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrowinvolvement by lymphoma. (Platelet transfusions to help patients meet eligibilitycriteria are not allowed within 3 days before study enrollment).

11. Life expectancy 6 months

12. A negative serum or urine pregnancy test prior to treatment must be available both forpre menopausal women and for women who are < 1 years after the onset of menopause.

13. Female patients of child bearing potential must use an effective method of birthcontrol (i.e. hormonal contraceptive, intrauterine device,diaphragm with spermicide,condom with spermicide or abstinence) during treatment period and 12 month thereafter;Males must use an effective method of birth control during treatment period and 12months thereafter.

Exclusion Criteria:

1. Other subtypes PTLD than monomorphic CD20 (+) DLBCL

2. Previous treatment for PTLD, DLBCL with immunotherapy or chemotherapy except forshort-term corticosteroids (duration of ≤ 8 days) before inclusion (Low dose steroidas immunosuppressant are allowed.)

3. central nervous system (CNS) involvement by lymphoma or any evidence of spinal cordcompression.

4. Prior history of malignancies other than lymphoma (except for basal cell or squamouscell carcinoma of the skin, early gastric cancer or carcinoma in situ of the cervix orbreast or untreated prostatic cancer without any plan for a treatment) unless thepatient has been free of the disease for ≥ 3 years

5. Patients with a known history of HIV or HCV seropositivity.

6. Patients with active hepatitis B i. HBsAg positive or ii. HBsAg negative, anti-HBc-Abpositive and HBV-DNA PCR positive patients

7. Pregnant or lactating women

8. Men who are not surgically sterile or women of childbearing potential not employingadequate contraception

9. Other serious illness or medical conditions i. Evidence of current uncontrolledcardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiacarrhythmias, symptomatic congestive heart failure, unstable angina, or myocardialinfarction within the past 6 months ii. History of significant neurological orpsychiatric disorders including dementia or seizures iii. Active, uncontrolledinfections requiring systemic antibiotic therapy or other serious infections within 14days before study enrollment iv. Other serious medical illnesses

10. Known hypersensitivity to any of the study drugs or its ingredients

11. Concomitant administration of any other experimental drug under investigation, orconcomitant chemotherapy, hormonal therapy, or immunotherapy.