ANHL1931

ANHL1931: A Randomized Phase 3 trial of Nivolumab in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

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Overview
Principal Investigator: Yun Choi, MD

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). 

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. 

Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. 

Chemotherapy drugs 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. 

Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL. 

Study details
Inclusion Criteria
  • Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by WHO criteria
  • ECOG performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma
  • Adequate renal function
Exclusion Criteria
  • Administration of prior anti-cancer therapy with the following exceptions:
    a. A short course (≤ 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms.
    b. A single course of COP (cyclophosphamide, vincristine, and prednisone)
    c. One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, or a pediatric mature B-NHL induction therapy that has not started more than 21 days prior to enrollment.
  • Active ischemic heart disease or heart failure.
  • Active uncontrolled infection
Study Requirements

Therapy will consist of 6 cycles of chemo-immunotherapy with or without nivolumab. Each cycle is 21 days.

Patients will then be randomized 1:1 to receive chemo-immunotherapy alone or chemo-immunotherapy + nivolumab. Following randomization, the patient may potentially be on one of the following six treatment arms:

  1. Arm A: DA-EPOCH-R
  2. Arm B: DA-EPOCH-R + nivolumab
  3. Arm C: R-CHOP
  4. Arm D: R-CHOP + nivolumab
  5. Arm E: R-CHOP + radiotherapy
  6. Arm F: R-CHOP + radiotherapy + nivolumab

FDG PET/CT will be performed at baseline, after cycle 2 (if feasible) and after cycle 6. 

Depending on outcome, some patients will go off therapy at the completion of chemotherapy. Other patients will then undergo Radiation Therapy. Some may undergo biopsy.