Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Imm… (NCT03321643) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
United States24 participantsStarted 2018-09-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed transformed diffuse large B-cell lymphoma (DLBCL), including histologic transformation from any indolent lymphoma (e.g. follicular or marginal zone lymphoma) or Richter transformation of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
* Patients must have measurable disease by CT or PET scan, with one or more sites of disease \>= 1.5 cm in longest dimension
* Relapsed or refractory disease after at least 1 prior regimen, defined using the 2014 Lugano classification
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of atezolizumab in patients \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Life expectancy of greater than 3 months
* Leukocytes \>= 2,500/mcL, unless documented bone marrow involvement by lymphoma
* Absolute neutrophil count \>= 1,000/mcL, unless documented bone marrow involvement by lymphoma
* Platelets \>= 75,000/mcL, unless documented bone marrow involvement by lymphoma
* Hemoglobin \>= 8 g/dL, unless documented bone marrow involvement by lymphoma
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic tran…
What they're measuring
1
Incidence of adverse events
Timeframe: Up to course 2 (42 days)
2
Maximum tolerated dose (MTD) and recommended phase 2 dose