NCT03064867

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

Phase I/II Trial of Venetoclax in Combination With R-ICE (V+RICE) Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Molly Gallogly · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, venetoclax, to a standard combination of chemotherapy drugs as a second treatment for relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab, ifosfamide, carboplatin, etoposide), a common set to cancer drugs used as a second line treatment for relapsed/refractory DLBCL. Venetoclax, is a new targeted anti-cancer drug, which works by mimicking a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the standard RICE regimen is believed to increase the chance of getting cancer into remission. Venetoclax is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of relapsed/refractory DLBCL. Venetoclax has been FDA approved for use in patients with chronic lymphocytic leukemia (CLL).

Detailed description

Primary Objective: Establishment of safety of V+RICE in order to identify the recommended Phase II dose (RPD2) Secondary Objectives: 1. Determine the overall response rate (ORR) of V+RICE relative to historical controls of RICE alone in r/r DLBCL. 2. Determine the proportion of patients who proceed to autologous stem cell transplantation after V+RICE relative to historical controls. 3. Describe the progression-free survival (PFS) and overall survival (OS) for patients treated with V + RICE who do and do not proceed to auto-Stem Cell Transplant, relative to historical controls. 4. Measure total number of peripheral blood stem cells collected in patients treated with V + RICE who proceed to stem cell mobilization/harvesting, compared to historical controls.

Conditions

• Diffuse Large B-cell-lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-26
• Primary completion: 2022-08-12
• Completion: 2023-08-12
• First posted: 2017-02-27
• Last updated: 2022-11-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study