Carfilzomib, Rituximab, and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 28, 2015

Primary Completion Date

July 20, 2021

Study Completion Date

June 29, 2023

Conditions
Contiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaStage I Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Large Cell Lymphoma
Interventions
DRUG

Carfilzomib

"Given IV, according to dose level. Cohorts begin with dose level (DL)1, escalated in standard 3+3 design to identify a recommended phase 2 dose DL (-2) 11 mg/m2 on day 1 and 2 every 21 days, cycles 1-6~DL (-1) 15 mg/m2 on days 1 and 2 every 21 days, cycles 1-6~DL (1) 20 mg/m2 days 1,2 every 21 days, cycles 1-6~DL (2) 20 mg/m2 days 1,2 of cycle 1 followed by 27 mg/m2 days 1,2 every 21 days for cycles 2-6.~DL (3) 20 mg/m2 days 1,2 of cycle 1 followed by 36 mg/m2 days 1,2 every 21 days for cycles 2-6.~DL(4) 20 mg/m2 days 1,2 of cycle 1 followed by 45 mg/m2 days 1,2 every 21 days for cycles 2-6~DL (5) 20 mg/m2 days 1,2 of cycle 1 followed by 56 mg/m2 days 1,2 every 21 days for cycles 2-6"

BIOLOGICAL

Rituximab

Given IV (375mg/m\^2)

DRUG

Cyclophosphamide

Given IV (750mg/m\^2)

DRUG

Doxorubicin hydrochloride

Given IV (50mg/m\^2)

DRUG

Vincristine sulfate

Given IV (1.4mg/m\^2)

DRUG

Prednisone

Given PO (100mg)

DRUG

Pegfilgrastim

6 mg SC day 4 (every 21 days). Filgrastim 300 or 480 mcg IV/SC daily days 1-10 may be substituted if pegfilgrastim is not available. ONPROTM is also an acceptable method of administration.

DRUG

Acyclovir

PO (400mg)

Trial Locations (3)

14263

Roswell Park Comprehensive Cancer Center, Buffalo

44106

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland

44195

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER

NCT02073097 - Carfilzomib, Rituximab, and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Lymphoma | Biotech Hunter | Biotech Hunter