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

NCT03064867 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-11-16

No results posted yet for this study

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).

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

Sponsors & Collaborators

  • Molly Gallogly

    lead OTHER

Principal Investigators

  • Molly Gallogly, MD PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2022-08-12
Completion
2023-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03064867 on ClinicalTrials.gov