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 range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. Age ≥ 19
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
complete response rate
Timeframe: 6 to 8 weeks after completion of the 6th cycle of treatment.
. 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
. Patients with a known history of HIV or HCV seropositivity.
. Patients with active hepatitis B i. HBsAg positive or ii. HBsAg negative, anti-HBc-Ab positive and HBV-DNA PCR positive patients
. Pregnant or lactating women
. Men who are not surgically sterile or women of childbearing potential not employing adequate contraception