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Monoclonal Antibodies

Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCL for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Aged 18 to 80 years old
* Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2) after at least 2 prior lines of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to be assessed up to approximately 5 years
Awards & highlights

Summary

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.

Who is the study for?
This trial is for adults with B-cell non-Hodgkin lymphoma (NHL) who have tried at least two other treatments without success. It's specifically aimed at those with certain types of NHL, like Follicular Lymphoma and Diffuse Large B-Cell Lymphoma.
What is being tested?
The study is testing AZD0486 as a single treatment option. Participants are divided into two groups based on their type of NHL: one group for Follicular Lymphoma (Module 1) and another for Diffuse Large B-Cell Lymphoma (Module 2).
What are the potential side effects?
While the specific side effects of AZD0486 aren't listed here, common side effects from similar cancer treatments include nausea, fatigue, fever, infections due to low blood cell counts, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to be assessed up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in EORTC IL233 scales
Change from baseline in FACT-LymS scales
Change from baseline in IL232 QL2 score
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCLExperimental Treatment1 Intervention
In Module 2, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R DLBCL. AZD0486 will be administered as intravenous infusion.
Group II: Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular LymphomaExperimental Treatment1 Intervention
In Module 1, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R FL. AZD0486 will be administered as intravenous infusion.

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,331 Previous Clinical Trials
288,639,845 Total Patients Enrolled
~160 spots leftby Feb 2027
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