Clinical trial NCT06549595: A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Official 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 (SOUNDTRACK-F1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Untreated Follicular Lymphoma
Keywords: Follicular Lymphoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 1015
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 10 years
measure: SRI Primary: Determination of the recommended Phase III dose (RP3D)
timeFrame: Up to 1 year
measure: Phase 3 Primary: To demonstrate the superiority of AZD0486 plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
timeFrame: Up to 10 years
Secondary outcomes:
measure: Safety Run in and Phase 3: ORR
timeFrame: Up to 10 years
measure: Safety Run In and Phase 3: CR Rate
timeFrame: Up to 10 years
measure: Safety Run In and Phase 3: CR at EoI
timeFrame: Up to 10 years
measure: Safety Run In and Phase 3: DoR
timeFrame: up to 10 years
measure: Safety Run In and Phase 3: PFS
timeFrame: Up to 10 years
measure: Safety Run In and Phase 3: OS
timeFrame: Up to 10 years
measure: Phase 3: CR rate at 30 months
timeFrame: Up to 10 Years
Other outcomes:
Locations:
city: Macquarie University
country: Australia
facility: Research Site
city: Nedlands
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hohhot
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Shatin
country: Hong Kong
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Okayama-shi
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: El Palmar
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Kaohsiung City
country: Taiwan
facility: Research Site
city: Kaohsiung city
country: Taiwan
facility: Research Site
city: Lukang Township
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Sir Charles Gairdner Hospital (SCGH)
name: Chan Cheah, MBBS FRACP FRCPA DMSc
role: PRINCIPAL_INVESTIGATOR
References: