Nivolumab and Combination Chemotherapy in Treating Participants With Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT03704714
Phase
PHASE1/PHASE2
Status
Suspended

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Prednisone — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 20, 2018
Status verified
Aug 2022
Primary completion
Dec 11, 2024
Completion
Jun 11, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab and R-CHOP)
    Participants receive nivolumab IV over 30 minutes on day 1. Participants also rituximab IV on day 2, cyclophosphamide IV on day 2, doxorubicin hydrochloride IV over 3-5 hours on day 2, vincristine sulfate IV over 30 minutes on day 2, and prednisone PO on days 2-6 of course 1 and rituximab IV on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV over 3-5 hours on day 1, vincristine sulfate IV over 30 minutes on day 1, and prednisone PO on days 1-5 of courses 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) for the combination treatment of nivolumab and R-CHOP [ Time Frame: Up to 18 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Northwestern University- Lake Forest HospitalLake ForestIllinois60045-
Northwestern Medicine: Delnor, DuPage, Warrenville, Kishwaukee (West Region)WarrenvilleIllinois60555-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILRush University Medical Center· Chicago, ILNorthwestern University- Lake Forest Hospital· Lake Forest, ILNorthwestern Medicine: Delnor, DuPage, Warrenville, Kishwaukee (West Region)· Warrenville, IL

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