OncRef

Clinical Trial: NCT03321643

Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-06-11

Study Overview

Brief Summary

This pilot phase I trial studies the side effects of atezolizumab, gemcitabine, oxaliplatin, and rituximab and to see how well they work in treating patients with transformed diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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 atezolizumab, gemcitabine, oxaliplatin, and rituximab may work better in treating patients with transformed diffuse large B-cell lymphoma.

Official Title

A Pilot Phase I Study of Atezolizumab (MPDL3280A) in Combination With Immunogenic Chemotherapy (Gemcitabine-Oxaliplatin) and Rituximab for Transformed Diffuse Large B-Cell Lymphoma

Conditions

Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Transformed Non-Hodgkin Lymphoma, Richter Syndrome, Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Intervention / Treatment

  • Drug: Atezolizumab
  • Procedure: Biopsy Procedure
  • Procedure: Biospecimen Collection
  • Procedure: Bone Marrow Biopsy
  • Procedure: Computed Tomography
  • Drug: Gemcitabine
  • Procedure: Magnetic Resonance Imaging
  • Drug: Oxaliplatin
  • Procedure: Positron Emission Tomography
  • Biological: Rituximab

Other Study ID Numbers

  • NCI-2017-01957
  • NCI-2017-01957
  • PHI-96
  • 10126
  • 10126
  • UM1CA186717

Start Date (Actual)

2018-09-18

Primary Completion Date (Estimated)

2027-06-30

Study Completion Date (Estimated)

2027-06-30

Enrollment (Estimated)

24

Study Type

Interventional

Phase

Phase 1