Study on AZD0486 for Treating Relapsed or Hard-to-Treat B-cell Non-Hodgkin Lymphoma
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06526793
This clinical trial is testing the effectiveness and safety of a new drug, AZD0486, for adults with B-cell non-Hodgkin lymphoma (NHL) that has returned or not responded to previous treatments. Participants must have tried at least two other therapies before joining this study.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate how well the drug AZD0486 works and how safe it is for adults aged 18 to 80 who have B-cell non-Hodgkin lymphoma (NHL) that has come back or is difficult to treat. The trial is divided into two parts: one for patients with follicular lymphoma (FL) and another for those with diffuse large B-cell lymphoma (DLBCL).
Description
This is a Phase II study conducted at multiple centers around the world. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study focuses on patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) and involves administering AZD0486 as an intravenous (IV) infusion. The main goal is to determine how effective and safe AZD0486 is when given at the recommended dose to adults between 18 and 80 years old who have B-NHL that has returned or not responded to previous treatments.
Eligibility Criteria
Inclusion Criteria
- Aged between 18 and 80 years.
- Diagnosed with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after trying at least two other treatments.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Cancer cells must show CD-19 markers after the last CD-19 targeted therapy.
- Have a disease that can be measured by scans, with at least one lymph node larger than 1.5 cm or an extranodal lesion larger than 1.0 cm.
- Have adequate blood cell counts and liver and kidney function as determined by specific tests.
- Patients with Gilbert's Syndrome are eligible if their bilirubin levels are elevated due to this condition.
Exclusion Criteria
- Have chronic lymphocytic leukemia (CLL), Burkitt lymphoma, or Richter's transformation.
- Have active cancer involvement in the central nervous system (CNS).
- Have a leukemic form of B-NHL.
- Have a history of significant brain or nervous system disorders, such as epilepsy or stroke.
- Have received certain cancer treatments recently, including T-cell engager therapy within 8 weeks, CAR T-cell therapy or autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant within 24 weeks.
- Require ongoing immunosuppressive therapy.
- Have unresolved side effects from previous treatments that are moderate to severe.
- Have a history of major heart problems.
- Female participants must not be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 33612 | Tampa | Florida |
| Research Site | 50314 | Des Moines | Iowa |
| Research Site | 66204 | Overland Park | Kansas |
| Research Site | 55905 | Rochester | Minnesota |
| Research Site | 63110 | Saint Louis | Missouri |
| Research Site | 08901 | New Brunswick | New Jersey |
| Research Site | 10016 | New York | New York |
| Research Site | 28203 | Charlotte | North Carolina |
| Research Site | 43210 | Columbus | Ohio |
| Research Site | 97239 | Portland | Oregon |
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