Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma
NCT03704714 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-08-15
Summary
This phase I/II trial studies the side effects and best dose of nivolumab and how well it works when giving together with combination chemotherapy in treating participants with diffuse large B-cell lymphoma. Monoclonal antibodies, such as nivolumab, interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and combination chemotherapy may work better in treating participants with diffuse large B-cell lymphoma.
Conditions
- Aggressive Non-Hodgkin Lymphoma
- B-Cell Non-Hodgkin Lymphoma
- CD20 Positive
- Diffuse Large B-Cell Lymphoma Unclassifiable
- Intravascular Large B-Cell Lymphoma
- Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
- Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
Given IV
- DRUG
-
Doxorubicin Hydrochloride
Given IV
- BIOLOGICAL
-
Given IV
- DRUG
-
Given PO
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- BIOLOGICAL
-
Given IV
- DRUG
-
Vincristine Sulfate
Given IV
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Reem Karmali, MD · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-20
- Primary Completion
- 2024-12-11
- Completion
- 2025-06-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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