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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06526793




Registration number
NCT06526793
Ethics application status
Date submitted
3/07/2024
Date registered
30/07/2024

Titles & IDs
Public title
AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL
Scientific title
A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma
Secondary ID [1] 0 0
D7404C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Non-Hodgkin Lymphoma 0 0
Follicular Lymphoma (FL) 0 0
Diffuse Large B-Cell Lymphoma (DLBCL) 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

Experimental: Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma - In Module 1, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R FL. AZD0486 will be administered as intravenous infusion.

Experimental: Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCL - In Module 2, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R DLBCL. AZD0486 will be administered as intravenous infusion.


Treatment: Drugs: AZD0486
Investigational Product administered via intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR)
Timepoint [1] 0 0
Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
Secondary outcome [1] 0 0
Duration of response (DoR)
Timepoint [1] 0 0
To be assessed up to approximately 5 years.
Secondary outcome [2] 0 0
Complete response (CR) rate
Timepoint [2] 0 0
To be assessed up through study completion, up to approximately 5 years
Secondary outcome [3] 0 0
Complete response (CR) rate
Timepoint [3] 0 0
To be assessed up through study completion, up to approximately 5 years
Secondary outcome [4] 0 0
Overall response rate (ORR)
Timepoint [4] 0 0
Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
Secondary outcome [5] 0 0
Duration of CR (DoCR)
Timepoint [5] 0 0
To be assessed up to approximately 5 years.
Secondary outcome [6] 0 0
Time to response (TTR)
Timepoint [6] 0 0
From the first dose until the first objective response, up to approximately 5 years.
Secondary outcome [7] 0 0
Event-free survival (EFS)
Timepoint [7] 0 0
To be assessed up to approximately 5 years
Secondary outcome [8] 0 0
Progression-free survival (PFS)
Timepoint [8] 0 0
To be assessed up to approximately 5 years.
Secondary outcome [9] 0 0
Time to next anti-lymphoma (TTNT)
Timepoint [9] 0 0
To be assessed up to approximately 5 years.
Secondary outcome [10] 0 0
Overall survival (OS)
Timepoint [10] 0 0
To be assessed up to approximately 5 years.
Secondary outcome [11] 0 0
Minimal residual disease (MRD)
Timepoint [11] 0 0
To be assessed up through study completion, up to approximately 5 years
Secondary outcome [12] 0 0
Change from baseline in EORTC IL233 scales
Timepoint [12] 0 0
To be assessed up through study completion, up to approximately 5 years
Secondary outcome [13] 0 0
Change from baseline in IL232 QL2 score
Timepoint [13] 0 0
To be assessed up through study completion, up to approximately 5 years
Secondary outcome [14] 0 0
Change from baseline in FACT-LymS scales
Timepoint [14] 0 0
To be assessed up through study completion, up to approximately 5 years
Secondary outcome [15] 0 0
Change from baseline in PGI-T scale
Timepoint [15] 0 0
To be assessed up through study completion, up to approximately 5 years

Eligibility
Key inclusion criteria
1. Key

* Aged 18 to 80 years old
* Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2) after at least 2 prior lines of therapy
* ECOG performance status 0 to 2
* Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy
* FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as > 1.5 cm in its longest dimension), or extranodal lesion (defined as > 1.0 cm in its longest dimension)
* Adequate hematological function: ANC = 1000/mm3, platelets

* 75,000/mm3, hemoglobin = 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening
* Adequate liver function: total bilirubin <1.5x ULN, AST/ALT = 3xULN Note: Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible)
* Adequate renal function: creatinine clearance (CrCl) of = 45 mL/min

The above is a summary, other inclusion criteria details may apply.
2. Key
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
* Active CNS involvement by B-NHL
* Leukemic presentation of B-NHL
* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
* Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy or autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, or prior allogeneic HSCT within 24 weeks of first dose of AZD0486
* Requires chronic immunosuppressive therapy
* Unresolved non hematological AEs = Grade 2 from prior therapies; history of = Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
* History of major cardiac abnormalities.
* If female, participant must not be pregnant or breastfeeding.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/05/2029
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Heidelberg
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - Macquarie University
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
NSW 2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Chemnitz
Country [19] 0 0
Germany
State/province [19] 0 0
Essen
Country [20] 0 0
Germany
State/province [20] 0 0
Wuerzburg
Country [21] 0 0
Japan
State/province [21] 0 0
Chiba-shi
Country [22] 0 0
Japan
State/province [22] 0 0
Kashiwa
Country [23] 0 0
Japan
State/province [23] 0 0
Koto-ku
Country [24] 0 0
Japan
State/province [24] 0 0
Kumamoto-shi
Country [25] 0 0
Japan
State/province [25] 0 0
Niigata-shi
Country [26] 0 0
Japan
State/province [26] 0 0
Okayama-shi
Country [27] 0 0
Japan
State/province [27] 0 0
Osaka-shi
Country [28] 0 0
Japan
State/province [28] 0 0
Yokohama-shi
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Pozuelo de Alarcon
Country [32] 0 0
Taiwan
State/province [32] 0 0
Kaohsiung City
Country [33] 0 0
Taiwan
State/province [33] 0 0
Kaohsiung
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taichung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Tainan City
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei City

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
Address 0 0
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: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements: thttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT06526793