Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

August 5, 2019

Primary Completion Date

May 31, 2026

Study Completion Date

March 31, 2030

Conditions
Non-Hodgkin's LymphomaDiffuse Large B-Cell LymphomaDLBCLNHL
Interventions
DRUG

DA-EPOCH

Vincristine 1.4 mg/m2 (2 mg cap) IV on Day 1, Doxorubicin 10 mg/m2/day CIVI on Days 1-4, Etoposide 50 mg/m2/day CIVI on Days 1-4, Cyclophosphamide 750 mg/m2 IV on Day 5. Prednisone 60 mg/m2 PO BID is administered daily on Days 1-5 of each cycle. Each cycle is 21 days and drugs will be given for 6 cycles.

BIOLOGICAL

Rituximab

Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for 6 cycles.

DRUG

CHOP

Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m2 IV, Vincristine 1.4 mg/m2 (2 mg cap) IV are administered on Day 1 of each 21-day cycle for 6 cycles. Prednisone 40 mg/m2 PO is administered daily on Days 1-5 of each cycle.

DRUG

Acalabrutinib

Acalabrutinib is administered orally at 100 mg twice a day for 14 days during the window period. During combination therapy, acalabrutinib is administered 100 mg twice daily for the first 10 days for 6 cycles.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH