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A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Recruiting
18-130 years
All
Phase 3

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Overview

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the AZD0486 plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

Description

The study consists of 2 sequential parts.

  1. Safety Run-in - this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D.
  2. Phase III - The Phase III part will assess the superiority of AZD0486 at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms
  3. Arm A: treatment with AZD0486 plus rituximab Schedule A
  4. Arm B: treatment with AZD0486 plus rituximab Schedule B
  5. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance and B-R + rituximab maintenance

Eligibility

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. Presence of >5000 circulating lymphoma cells
  5. Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study

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

Study details
    Untreated Follicular Lymphoma

NCT06549595

AstraZeneca

15 October 2025

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