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

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Untreated Follicular Lymphoma

Treatments: Drug: AZD0486; Drug: R-CHOP; Drug: R-CVP; Drug: BR

Study type: Interventional

Funder types: Industry

Identifiers

NCT06549595

2023-510098-33-00 (Registry Identifier)

D7401C00001

Details and patient eligibility

About

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.

Full 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

   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

Enrollment: 1,015 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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 FL Grades 1-3A per WHO 2016 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. Adequate liver, hematological, renal and cardiac function.

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

Exclusion criteria

1. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,015 participants in 3 patient groups

Rituximab, AZD0486 - A

Experimental group

Description:

AZD0486 regimen A plus rituximab

Treatment:

Drug: AZD0486

Rituximab, AZD0486 - B

Experimental group

Description:

AZD0486 regimen B plus rituximab

Treatment:

Drug: AZD0486

Chemoimmunotherapy

Active Comparator group

Description:

Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP or R-CVP followed by rituximab maintenance, or B-R)

Treatment:

Drug: BR

Drug: R-CVP

Drug: R-CHOP