NCT04094142

Acalabrutinib With Rituximab and Lenalidomide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Phase II Trial of Acalabrutinib With Rituximab and Lenalidomide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NCCN guidelines for B cell lymphoma suggest that patients with relapsed/refractory aggressive NHL who are candidate for high-dose therapy should receive combination of cytotoxic chemotherapies as 2nd line treatment. However, proportion of patients who are adequately salvaged by second line chemotherapy and high-dose chemotherapy with stem cell rescue is unsatisfactory. Moreover, many fragile patients are unfit for salvage cytotoxic chemotherapy and/or high-dose chemotherapy. Hence, most of patients with relapsed/refractory aggressive B-cell NHL is ultimately candidate for less-cytotoxic drugs with targeted approach. This trial is phase II trial of acalabrutinib in combination with rituximab and lenalidomide for these patients.

Conditions

• Non-hodgkin Lymphoma,B Cell

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Acalabrutinib, lenalidomide, rituximab will be given as described in the "Arms" decriptions. Day 1 to day 28 is considered one cycle, and cycles will be repeated every 4-weeks, for 6 cycles. After 6 cycles, maintenance of acalabrutinib 100mg bid will be administered up to 1 year for subjects whose best responses- to the regimen are partial response or complete remission.

Timeline

• Start date: 2019-07-09
• Primary completion: 2022-05-15
• Completion: 2022-05-15
• First posted: 2019-09-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: South Korea