Nivolumab With DA-REPOCH Chemotherapy Regimen in Treating Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
David Bond, MD
Study ID
NCT03749018
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Aggressive Non-Hodgkin Lymphoma
  • Ann Arbor Stage I Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Ann Arbor Stage II B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage II Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage III Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Indolent Non-Hodgkin Lymphoma
  • Mediastinal B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
  • Transformed Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Give IV

Study Details

This phase II trial studies how well nivolumab works with the DA-REPOCH chemotherapy regimen in treating patients with aggressive B-cell non-Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as dose-adjusted rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-REPOCH), 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 with DA-REPOCH may work better in treating patients with aggressive B-cell non-Hodgkin lymphoma.

Key Dates

Start date
Jan 2, 2019
Status verified
Feb 2026
Primary completion
Feb 2, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Treatment (nivolumab, DA-REPOCH)
    Patients receive rituximab IV and nivolumab IV over 60 minutes on day 1. Patients also receive etoposide, vincristine sulfate and doxorubicin hydrochloride IV continuously over 96 hours, cyclophosphamide IV bolus, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After course 6, patients receive nivolumab IV over 60 minutes on day 1 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From start of treatment to progression or death, whichever occurs first, assessed at 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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