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| Name | Class |
|---|---|
| Cheolwon Suh | UNKNOWN |
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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.
Monomorphic PTLD comprise more than 70% of PTLDs and diffuse large B-cell lymphoma is the predominant subtype. However, none of the trials have been performed for the specific population of DLBCL type monomorphic PTLD. The investigators will select Patients with proven, measurable monomorphic PTLD of DLBCL after solid organ transplantation (e.g. heart, lung, liver or kidney etc.). Patients having PTLD with or without Epstein-Barr virus (EBV) association, positive for CD20 monomorphic DLBCL type. The B-R treatment will continue up to 6 cycles with interval of 21 days. Patients will receive 375 mg/m2 on day 1 and bendamustine 120 mg/m2 by intravenous infusion on day 2 and 3 in the first cycle. From the 2nd to 6th cycle, rituximab will be administered subcutaneously at a fixed dose of 1400 mg and bendamustine 120 mg/m2 by intravenous infusion on day 1 following administration of rituximab and day 2. On the first day of infusion of bendamustine in each cycle, palonosetron 0.25 mg will be given as a single intravenous injection about 30 minutes before infusion of bendamustine. Pegfilgrastim 6 mg will be administered as a single subcutaneous injection between 24 to 48 hours after completion of chemotherapy at each cycle. Based on relatively good safety profile and efficacy of bendamustine and rituximab (BR regimen), the investigators will investigate a feasibility of BR regimen in this immunocompromised patients with DLBCL type monomorphic PTLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bendamustine, rituximab | Experimental | Bendamustine plus subcutaneous Rituximab treatment of 6 cycles. Rituximab 1400mg subcutaneous over 5mins on day 1 and bendamustine 120mg/m2 + NS 500mL iv over 1hour on day 1 and 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bendamustine, rituximab | Drug | subjects will receive rituximab 375mg/m2 on day 1 and bendamustine 120mg/m2 by intravenous infusion on day 2 and 3 in the first cycle. From the 2nd to 6th cycle, rituximab will be administered subcutaneously at a fixed dose of 1400mg and bendamustine 120mg/m2 by intravenous infusion on day 1 following administration of rituximab and day 2. |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | 6 to 8 weeks after completion of the 6th cycle of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess response rate | 2 to 3 weeks (or start of next cycle) after completion of the 3rd cycle of treatment and 6 to 8 weeks after completion of the 6th cycle of treatment. | |
| Assess event-free survival | the time from the 1st day of treatment to the first recording of disease-progression, relapse or death of any cause or failure to achieve CR after completion, assessed up to 96 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dok Hyun Yoon, M.D., PhD | Contact | 82-10-3235-3090 | dhyoon@amc.seoul.kr | |
| Cheolwon Suh, M.D., PhD | Contact | 82-10-3735-3209 | csuh@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Wonseog Kim, M.D., PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
we will share collected data with principal investigators in Korea
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| Assess overall survival | the time from the 1st day of treatment to death of any cause or the date of last follow-up, assessed up to 96 months. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From the date of first drug administration until the date of the 28th days of last drug administration, assessed up to 22 weeks |
| Assess health-related quality of life by EORTC QLQ-C30 (3rd edition) | within 14 days prior to treatment start and every 12 months (± 1 months) of follow-up period until final analysis and at the time of disease progression, assessed up to 96 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |