Combining AZD0486 with Rituximab for Untreated Follicular Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, randomized, Phase III study evaluates the efficacy and safety of AZD0486 in combination with rituximab in patients with untreated follicular lymphoma. The study consists of a safety run-in to determine the recommended phase 3 dose (RP3D) of AZD0486, followed by a Phase III comparison of this combination against standard immunochemotherapy regimens chosen by investigators. Participants will be assigned to one of three treatment arms: two AZD0486 plus rituximab schedules or a comparator arm with standard regimens. The goal is to assess whether the new combination offers superior outcomes compared to existing treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification
3. ECOG performance status of 0 to 2
4. No prior systemic lymphoma-directed therapy
5. Need for systemic treatment meeting at least 1 GELF criteria
6. FDG-avid and measurable disease
7. Stage II to IV and FLIPI 2-5 \[Phase III only\]
8. Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion Criteria:

1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
2. Contra-indication to BR, RCVP, and R-CHOP
3. Participants with or history of CNS lymphoma
4. History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
5. Presence of \>5000 circulating lymphoma cells
6. Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

Where it's running

• Research Site
  Huntsville, Alabama, United States Recruiting
• Research Site
  Anchorage, Alaska, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Los Alamitos, California, United States Recruiting
• Research Site
  New Haven, Connecticut, United States Recruiting
• Research Site
  Jacksonville, Florida, United States Recruiting

+194 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Chan Cheah, MBBS FRACP FRCPA DMSc — Sir Charles Gairdner Hospital (SCGH)
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.