Study on Venetoclax Plus R-ICE Chemotherapy for Difficult or Returning Diffuse Large B-Cell Lymphoma
Sponsor: Molly Gallogly
ClinicalTrials ID:NCT03064867
This clinical trial is testing a new treatment by adding the drug venetoclax to a standard chemotherapy regimen called R-ICE for patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The aim of this study is to find the right dose and ensure the safety of adding venetoclax, a new cancer drug, to the standard chemotherapy treatment R-ICE (rituximab, ifosfamide, carboplatin, etoposide) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). Venetoclax works by targeting a specific protein in cancer cells, causing them to die. Although venetoclax is approved for chronic lymphocytic leukemia, it is still experimental for DLBCL.
Description
The main goal of this study is to determine the safe dose of venetoclax when combined with R-ICE chemotherapy. Researchers will also look at how well this combination works compared to the standard R-ICE treatment alone. They will measure how many patients can proceed to stem cell transplantation after receiving the treatment and track the survival rates of patients who do and do not undergo transplantation. Additionally, the study will assess the number of stem cells collected from patients who undergo stem cell harvesting after treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after previous treatment with rituximab and anthracycline-based chemotherapy.
- Have received no more than two prior treatments for lymphoma.
- Be in relatively good health with an ECOG performance status of 0 to 2.
- Have normal organ and bone marrow function, including specific blood counts and liver and kidney function tests.
- Meet specific guidelines for hepatitis B testing and eligibility.
- Be able to understand and sign a consent form.
- Women of childbearing potential must agree to use effective contraception during treatment and for a specified period after.
- Men must agree to use contraception and refrain from donating sperm during treatment and for a specified period after.
Exclusion Criteria
- Have unresolved side effects from previous treatments.
- Be receiving other investigational drugs.
- Have active tumor lysis syndrome.
- Have active central nervous system disease.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled illnesses.
- Be HIV-positive and on antiretroviral therapy.
- Have positive test results for hepatitis B or C.
- Be pregnant or breastfeeding.
- Have conditions that prevent oral medication intake.
- Have had chemotherapy or radiation within three weeks of starting the study.
- Have another active cancer within the last two years, with some exceptions.
- Have had major surgery within two weeks.
- Require high-dose steroids.
- Have allergies to certain medications.
- Be using warfarin or certain other medications that interact with venetoclax.
- Have received live vaccines recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Washington University School of Medicine, Siteman Cancer Center | 63110 | St Louis | Missouri |
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | 44106-5065 | Cleveland | Ohio |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | 44195 | Cleveland | Ohio |
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