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AZD0486 + Rituximab for Follicular Lymphoma

Phase 3

Recruiting

Led By Chan Cheah, MBBS FRACP FRCPA DMSc

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be at least 18 years of age, inclusive, at the time of signing the ICF

ECOG performance status of 0 to 2

Must not have

Contra-indication to BR, RCVP, and R-CHOP

Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new combination of drugs (AZD0486 and rituximab) for effectiveness and safety compared to the standard treatment options for patients with untreated follicular lymphoma.

Who is the study for?

This trial is for patients with untreated Follicular Lymphoma. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided here.

What is being tested?

The study tests the effectiveness and safety of a new combination: AZD0486 plus rituximab against standard immunochemotherapy regimens (R-CHOP, R-CVP, BR) in untreated Follicular Lymphoma patients.

What are the potential side effects?

While specific side effects are not listed here, typical reactions may include those common to chemotherapy and immunotherapy such as nausea, fatigue, increased infection risk, and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can care for myself and am up and about more than 50% of my waking hours.

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I have not received any treatment for lymphoma.

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My lymphoma is classified as FL Grade 1-3A.

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I need treatment for my condition as per GELF guidelines.

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My cancer shows up on PET scans and can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive BR, RCVP, or R-CHOP treatments due to health reasons.

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My lymphoma is either Grade 3B or suspected to be transforming into a more aggressive form.

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I have or had CNS lymphoma.

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I do not have any serious infections requiring treatment that would make joining the study unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 3 Primary: To demonstrate the superiority of AZD0486 plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy

SRI Primary: Determination of the recommended Phase III dose (RP3D)

SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs

Secondary study objectives

Phase 3: CR rate at 30 months

Safety Run In and Phase 3: CR Rate

Safety Run In and Phase 3: CR at EoI

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