NCT02753062

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

Multicenter Phase II Study of Bendamustine Plus Subcutaneous Rituximab in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Type Monomorphic Post-transplant Lymphoproliferative Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	bendamustine, rituximab	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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-08-01
• Completion: 2023-08-01
• First posted: 2016-04-27
• Last updated: 2016-04-27

Locations

1 site across 1 country: South Korea