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A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
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.
Study details:
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.
1. Arm A: treatment with AZD0486 plus rituximab Schedule A. 2.
Arm B: treatment with AZD0486 plus rituximab Schedule B. 3. 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-07
Primary completion: 2031-04-15
Study completion finish: 2035-02-28
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06549595
Intervention or treatment
DRUG: AZD0486
DRUG: R-CHOP
DRUG: R-CVP
DRUG: BR
Conditions
- • Untreated Follicular Lymphoma
Find a site
Closest Location:
Research Site
Research sites nearby
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Research Site
Macquarie University, Not Specified, Australia
Research Site
Nedlands, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Rituximab, AZD0486 - A
| DRUG: AZD0486
|
EXPERIMENTAL: Rituximab, AZD0486 - B
| DRUG: AZD0486
|
ACTIVE_COMPARATOR: Chemoimmunotherapy
| DRUG: R-CHOP
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 | Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures. | Up to 10 years |
| SRI Primary: Determination of the recommended Phase III dose (RP3D) | The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the safety run-in part | Up to 1 year |
| Phase 3 Primary: To demonstrate the superiority of AZD0486 plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy | PFS, based on Lugano 2014 Response Criteria, as assessed by BICR. | Up to 10 years |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Safety Run in and Phase 3: ORR | ORR defined as the proportion of participants achieving either a PR or CR at any time based on Lugano 2014 Response Criteria | Up to 10 years |
| Safety Run In and Phase 3: CR Rate | CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria | Up to 10 years |
| Safety Run In and Phase 3: CR at EoI | Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria | Up to 10 years |
| Safety Run In and Phase 3: DoR | DoR will be defined as the time from the time of first response until progression based on Lugano 2014 criteria | up to 10 years |
| Safety Run In and Phase 3: PFS | PFS is defined as time until disease progression based on Lugano 2014 Response Criteria | Up to 10 years |
| Safety Run In and Phase 3: OS | OS is defined as time until the date of death | Up to 10 years |
| Phase 3: CR rate at 30 months | Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria | Up to 10 Years |
Frequently Asked Questions
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