Trial Title:
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
NCT ID:
NCT06549595
Condition:
Untreated Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Conditions: Keywords:
Follicular Lymphoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD0486
Description:
a fully human bispecific monoclonal IgG4 antibody
Arm group label:
Rituximab, AZD0486 - A
Arm group label:
Rituximab, AZD0486 - B
Intervention type:
Drug
Intervention name:
R-CHOP
Description:
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Arm group label:
Chemoimmunotherapy
Intervention type:
Drug
Intervention name:
R-CVP
Description:
Rituximab, Cyclophosphamide, Vincristine and Prednisone
Arm group label:
Chemoimmunotherapy
Intervention type:
Drug
Intervention name:
BR
Description:
Bendamustine, Rituximab
Arm group label:
Chemoimmunotherapy
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Macquarie University
Zip:
2109
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brussels
Zip:
1090
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Brussel
Zip:
1000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Mechelen
Zip:
2800
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Oshawa
Zip:
L1G 2B9
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chicoutimi
Zip:
G7H 5H6
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4J 1C5
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tampere
Zip:
33521
Country:
Finland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hong Kong
Zip:
00000
Country:
Hong Kong
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shatin
Zip:
00000
Country:
Hong Kong
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Okayama-shi
Zip:
700-8558
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
13620
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8036
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Girona
Zip:
17007
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Las Palmas de Gran Canaria
Zip:
35020
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Falun
Zip:
79182
Country:
Sweden
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Uppsala
Zip:
75185
Country:
Sweden
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Changhua
Zip:
50006
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung City
Zip:
80756
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung city
Zip:
833
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Lukang Township
Zip:
505029
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
704
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei City
Zip:
106
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
06620
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
6200
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
EC1M6BQ
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
August 7, 2024
Completion date:
February 28, 2035
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06549595
