NCT03949062

Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of iR2 (Ibrutinib，Lenalidomide, Rituximab）in Untreated and Unfit Elderly Patients With Diffuse Large B-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。

Detailed description

This open-label, single arm study will evaluate the efficacy and safety of ibrutinib， lenalidomide, rituximab (iR2) in previously untreated and unfit elderly subjects with diffuse large B-cell lymphoma. Subjects will receive 6 cycles of ibrutinib 560mg, day 1-21, orally (PO) , lenalidomide 25mg, day 1-10, rituximab 375mg/m2, intravenously, every 21 days.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
DRUG	Lenalidomide	Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
DRUG	Rituximab	Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles

Timeline

• Start date: 2019-03-13
• Primary completion: 2021-03-01
• Completion: 2022-05-01
• First posted: 2019-05-14
• Last updated: 2021-02-17

Locations

1 site across 1 country: China