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

Last updated: March 13, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Follicular Lymphoma

Lymphoma

Treatment

R-CVP

R-CHOP

BR

Clinical Study ID

NCT06549595
D7401C00001
2023-510098-33-00
  • Ages 18-130
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be at least 18 years of age, inclusive, at the time of signing theICF.

  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

Exclusion Criteria:

  1. Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologictransformation 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 placesparticipant at unacceptable risk if he/she were to participate in the study

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

Study Design

Total Participants: 1015
Treatment Group(s): 4
Primary Treatment: R-CVP
Phase: 3
Study Start date:
August 07, 2024
Estimated Completion Date:
February 28, 2035

Study 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

Connect with a study center

  • Research Site

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Research Site

    Brussel, 1000
    Belgium

    Site Not Available

  • Research Site

    Brussels, 1090
    Belgium

    Site Not Available

  • Research Site

    Gent, 9000
    Belgium

    Site Not Available

  • Research Site

    Mechelen, 2800
    Belgium

    Site Not Available

  • Research Site

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Research Site

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • Research Site

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Research Site

    Beijing, 100142
    China

    Site Not Available

  • Research Site

    Tianjin, 300020
    China

    Site Not Available

  • Research Site

    Helsinki, 00029
    Finland

    Site Not Available

  • Research Site

    Kuopio, 70029
    Finland

    Site Not Available

  • Research Site

    Tampere, 33520
    Finland

    Site Not Available

  • Research Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Research Site

    Shatin, 00000
    Hong Kong

    Site Not Available

  • Research Site

    Budapest, 1122
    Hungary

    Site Not Available

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Okayama-shi, 700-8558
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Gliwice, 44-102
    Poland

    Site Not Available

  • Research Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Research Site

    El Palmar, 30120
    Spain

    Site Not Available

  • Research Site

    Girona, 17007
    Spain

    Site Not Available

  • Research Site

    Las Palmas de Gran Canaria, 35020
    Spain

    Site Not Available

  • Research Site

    Madrid, 28040
    Spain

    Site Not Available

  • Research Site

    Oviedo, 33011
    Spain

    Site Not Available

  • Research Site

    Pamplona, 31008
    Spain

    Site Not Available

  • Research Site

    Santander, 39008
    Spain

    Site Not Available

  • Research Site

    Falun, 79182
    Sweden

    Site Not Available

  • Research Site

    Uppsala, 75185
    Sweden

    Site Not Available

  • Research Site

    Changhua, 50006
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung city, 833
    Taiwan

    Active - Recruiting

  • Research Site

    Lukang Township, 505029
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 704
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 106
    Taiwan

    Active - Recruiting

  • Research Site

    Ankara, 06620
    Turkey

    Site Not Available

  • Research Site

    London, EC1M6BQ
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.