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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06549595




Registration number
NCT06549595
Ethics application status
Date submitted
29/07/2024
Date registered
12/08/2024

Titles & IDs
Public title
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Scientific title
A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma
Secondary ID [1] 0 0
D7401C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Untreated Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD0486
Treatment: Drugs - R-CHOP
Treatment: Drugs - R-CVP
Treatment: Drugs - BR

Experimental: Rituximab, AZD0486 - A - AZD0486 regimen A plus rituximab

Experimental: Rituximab, AZD0486 - B - AZD0486 regimen B plus rituximab

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


Treatment: Drugs: AZD0486
a fully human bispecific monoclonal IgG4 antibody

Treatment: Drugs: R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Treatment: Drugs: R-CVP
Rituximab, Cyclophosphamide, Vincristine and Prednisone

Treatment: Drugs: BR
Bendamustine, Rituximab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 10 years
Primary outcome [2] 0 0
SRI Primary: Determination of the recommended Phase III dose (RP3D)
Timepoint [2] 0 0
Up to 1 year
Primary outcome [3] 0 0
Phase 3 Primary: To demonstrate the superiority of AZD0486 plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [1] 0 0
Safety Run in and Phase 3: ORR
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Safety Run In and Phase 3: CR Rate
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Safety Run In and Phase 3: CR at EoI
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [4] 0 0
Safety Run In and Phase 3: DoR
Timepoint [4] 0 0
up to 10 years
Secondary outcome [5] 0 0
Safety Run In and Phase 3: PFS
Timepoint [5] 0 0
Up to 10 years
Secondary outcome [6] 0 0
Safety Run In and Phase 3: OS
Timepoint [6] 0 0
Up to 10 years
Secondary outcome [7] 0 0
Phase 3: CR rate at 30 months
Timepoint [7] 0 0
Up to 10 Years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2035
Actual
Sample size
Target
1005
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Macquarie University
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussel
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Mechelen
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Tianjin
Country [9] 0 0
Finland
State/province [9] 0 0
Helsinki
Country [10] 0 0
Finland
State/province [10] 0 0
Tampere
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Poland
State/province [12] 0 0
Gliwice
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
El Palmar
Country [15] 0 0
Spain
State/province [15] 0 0
Girona
Country [16] 0 0
Spain
State/province [16] 0 0
Las Palmas de Gran Canaria
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Oviedo
Country [19] 0 0
Spain
State/province [19] 0 0
Pamplona
Country [20] 0 0
Spain
State/province [20] 0 0
Santander
Country [21] 0 0
Sweden
State/province [21] 0 0
Falun
Country [22] 0 0
Sweden
State/province [22] 0 0
Uppsala
Country [23] 0 0
Taiwan
State/province [23] 0 0
Changhua
Country [24] 0 0
Taiwan
State/province [24] 0 0
Kaohsiung City
Country [25] 0 0
Taiwan
State/province [25] 0 0
Kaohsiung city
Country [26] 0 0
Taiwan
State/province [26] 0 0
Lukang Township
Country [27] 0 0
Taiwan
State/province [27] 0 0
Tainan City
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei City
Country [29] 0 0
Turkey
State/province [29] 0 0
Ankara
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chan Cheah, MBBS FRACP FRCPA DMSc
Address 0 0
Sir Charles Gairdner Hospital (SCGH)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06549595