AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
About this study
The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.
- Condition
- Large B-cell Lymphoma
- Tested
- AZD0486, R-mini-CHOP
- Sponsor
- AstraZeneca
Who can join
- Age
- 65 to 130 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 19
- Minimum age: 65 years
- Maximum age: 130 years
- Study condition: Large B-cell Lymphoma
- 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.
Where
68 sites, 63 recruiting
Research Site
Melbourne, Australia
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Yvoir, Belgium
Research Site
Porto Alegre, Brazil
Research Site
São Paulo, Brazil
and 62 more sites on ClinicalTrials.gov
Contact
-
AstraZeneca Clinical Study Information Center
1-877-240-9479 information.center@astrazeneca.com
Potential match only. Final eligibility is determined by the study team.