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โ† Trials
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AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

RecruitingPhase 3Ages 65 Years - 130 YearsAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to measure the efficacy and safety of R-mini-CHOP ร— 2 followed by AZD0486 compared with R-mini-CHOP ร— 6 in elderly or unfit participants newly diagnosed with LBCL.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment; * Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma; * FDG-avid and measurable disease as per Lugano and Ann Arbor staging; * Stage I bulky (7.5 cm and greater) to Stage IV; * ECOG performance status 0 to 2; * Adequate bone marrow, liver, renal and cardiac function. The above is a summary, other inclusion criteria details may apply. * As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol * Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma). * History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition * Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). * Active or uncontrolled infection * Major cardiac abnormalities * Prior anti-lymphoma therapy except for corticosteroids for symptom control * Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions The above is a summary, other exclusion criteria details may apply.
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What it tests

  • AZD0486
  • R-mini-CHOP
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Where

82 sites
Research Site
Clayton, Australia
Research Site
Macquarie University, Australia
Research Site
Melbourne, Australia
Research Site
Nedlands, Australia
Research Site
Waratah, Australia
Research Site
Antwerp, Belgium
Research Site
Brussels, Belgium
Research Site
Ghent, Belgium

โ€ฆand 74 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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