Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell Lymphoma (NCT02753062) | Clinical Trial Compass
UnknownPhase 2
Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell Lymphoma
South Korea22 participantsStarted 2015-08
Plain-language summary
This is an open-label, multi-center, prospective, single arm phase 2 trial of the combination of bendamustine and rituximab in patients with PTLD, monomorphic cluster of differentiation antigen 20(CD20) positive DLBCL. The investigators want to investigate the efficacy and safety of the combination of bendamustine and rituximab in patients with previously untreated PTLD, monomorphic CD20 (+) diffuse large B-cell lymphoma.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Histologically confirmed adult patients diagnosed with CD20-positive monomorphic PTLD, DLBCL irrespective of EBV association
✓. Patients having undergone solid organ transplantation (heart, lung, liver, kidney, pancreas, small intestine transplantation, etc or a combination of the organ transplantations mentioned).
✓. No prior treatment for PTLD, DLBCL except reduction of immunosuppression
✓. At least one measurable lesion ≥ 1.5 cm in greatest transverse diameter by spiral CT
✓. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
✕. Other subtypes PTLD than monomorphic CD20 (+) DLBCL
✕. Previous treatment for PTLD, DLBCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before inclusion (Low dose steroid as immunosuppressant are allowed.)
✕. central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression.
✕. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
What they're measuring
1
complete response rate
Timeframe: 6 to 8 weeks after completion of the 6th cycle of treatment.