Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (NCT02436707) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma
Canada129 participantsStarted 2015-10-27
Plain-language summary
The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
Who can participate
Age range16 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients with histologic diagnosis for one of the following histologies according to the World Health Organization: documented at initial diagnosis or at relapse:
* Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma);
* Previous indolent lymphoma (follicular lymphoma, marginal zone lymphoma, including extranodal MALT lymphoma, lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at most recent relapse (biopsy proof of transformation is mandatory);
* Unclassifiable B-cell lymphoma with indeterminate features between diffuse large B-cell lymphoma and Burkitt lymphoma.
* Biopsy proof of disease at initial diagnosis is mandatory. A repeat biopsy in primary refractory disease is preferred but not mandatory to confirm progressive disease. A biopsy at relapse is preferred but not mandatory. Participating centres must designate a local reference expert pathologist who will confirm the diagnosis for the patients enrolled at that centre.
* Patients must be CD20+ in order to be eligible for the study.
* Clinically and/or radiologically measurable disease (one site bidimensionally measurable). Measurements/ evaluations must be done within 28 days prior to randomization.
* Prior FDG-PET scan, if done at baseline, must be positive (known FDG-avid lymphoma)
* Patients with de novo aggressive B-cell lymphoma must have relapsed or progressed, or have refractory disease, after…