Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 26, 2017

Primary Completion Date

August 12, 2022

Study Completion Date

August 12, 2023

Conditions
Diffuse Large B-cell-lymphoma
Interventions
DRUG

Venetoclax

"Beginning with 400mg daily on days 1-10 of cycle 1-3~Phase I dose escalation scheme:~Dose Level -2 (DL-2): 100 mg daily, days 1-10, cycle 1-3~DL-1: 200 mg daily, days 1-10, cycle 1-3~DL1: 400 mg daily, days 1-10, cycle 1-3~DL2: 600 mg daily, days 1-10, cycle 1-3~DL3: 800 mg daily, days 1-10, cycle 1-3~Phase II: Given at a dose of 400mg daily for 5 days"

DRUG

Rituximab

"Part of R-ICE treatment:~Rituximab: 375 mg/m\^2 intravenously (IV) on Day 1 of R-ICE every 21 days"

DRUG

Ifosfamide

"Part of R-ICE treatment:~Ifosfamide: 5,000 mg/m\^2 mixed together with mesna at a dose of 5,000 mg/m\^2 over 24 hours beginning on Day 2 and completing on Day 3 of each 21-day cycle"

DRUG

Carboplatin

"Part of R-ICE treatment:~Carboplatin: At a dose corresponding to an AUC = 5 based on Cockcroft-Gault calculation of GFR using adjusted body weight. Carboplatin is given IV on the Day 2 of RICE of each 21 day cycle"

DRUG

Etoposide

"Part of R-ICE treatment:~Etoposide: 100 mg/m2by IV daily on 3 consecutive days (Days 1-3) of each 21-day cycle"

Trial Locations (3)

44195

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

63110

Washington University School of Medicine, Siteman Cancer Center, St Louis

44106-5065

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

All Listed Sponsors
lead

Molly Gallogly

OTHER

NCT03064867 - Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma | Biotech Hunter | Biotech Hunter