Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT06549595
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2024-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571759', 'term': 'R-CHOP protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1015}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-11-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-11-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.'}, {'measure': 'SRI Primary: Determination of the recommended Phase III dose (RP3D)', 'timeFrame': 'Up to 1 year', 'description': 'The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the safety run-in part'}, {'measure': "Phase 3 Dual Primary: To demonstrate the superiority of AZD0486 plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy", 'timeFrame': 'Up to 10 years', 'description': 'PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.'}, {'measure': "Phase 3 Dual Primary: To demonstrate the superiority of AZD0486 plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy", 'timeFrame': 'Up to 10 years', 'description': 'ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.'}], 'secondaryOutcomes': [{'measure': 'Safety Run in and Phase 3: ORR at EoI (Investigator assessed)', 'timeFrame': 'Up to 10 years', 'description': 'ORR defined as the proportion of participants achieving either a PR or CR at End of Induction based on Lugano 2014 Response Criteria'}, {'measure': 'Safety Run In and Phase 3: CR Rate', 'timeFrame': 'Up to 10 years', 'description': 'CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria'}, {'measure': 'Safety Run In and Phase 3: CR at EoI', 'timeFrame': 'Up to 10 years', 'description': 'Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria'}, {'measure': 'Safety Run In and Phase 3: DoR', 'timeFrame': 'up to 10 years', 'description': 'DoR will be defined as the time from the time of first response until progression based on Lugano 2014 criteria'}, {'measure': 'Safety Run In and Phase 3: PFS (Investigator assessed)', 'timeFrame': 'Up to 10 years', 'description': 'PFS (Investigator assessed) is defined as time until disease progression based on Lugano 2014 Response Criteria'}, {'measure': 'Safety Run In and Phase 3: OS', 'timeFrame': 'Up to 10 years', 'description': 'OS is defined as time until the date of death'}, {'measure': 'Phase 3: CR rate at 30 months (CR30)', 'timeFrame': 'Up to 30 months', 'description': 'Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria'}, {'measure': 'Phase 3: Time to First Subsequent Therapy or Death (TFST)', 'timeFrame': 'Up to 10 Years', 'description': 'TFST will be defined as the time from the time until the start date of first subsequent anti-lymphoma therapy or death.'}, {'measure': 'Phase 3: Time from randomisation to second progression or death (PFS2)', 'timeFrame': 'Up to 10 Years', 'description': 'PFS2 will be defined as the time until the earliest of the progression event, after first subsequent therapy, or death'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Follicular Lymphoma'], 'conditions': ['Untreated Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "The study consists of 2 sequential parts.\n\n1. Safety Run-in - this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D.\n2. 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\n\n 1. Arm A: treatment with AZD0486 plus rituximab Schedule A\n 2. Arm B: treatment with AZD0486 plus rituximab Schedule B\n 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 + rituximab maintenance"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.\n2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification\n3. ECOG performance status of 0 to 2\n4. No prior systemic lymphoma-directed therapy\n5. Need for systemic treatment meeting at least 1 GELF criteria\n6. FDG-avid and measurable disease\n7. Stage II to IV and FLIPI 2-5 \\[Phase III only\\]\n8. Adequate liver, hematological, renal and cardiac function.\n\nThe above is a summary, other inclusion criteria details may apply\n\nExclusion Criteria:\n\n1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma\n2. Contra-indication to BR, RCVP, and R-CHOP\n3. Participants with or history of CNS lymphoma\n4. Presence of \\>5000 circulating lymphoma cells\n5. Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study\n\nThe above is a summary, other exclusion criteria details may apply'}, 'identificationModule': {'nctId': 'NCT06549595', 'briefTitle': 'A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'D7401C00001'}, 'secondaryIdInfos': [{'id': '2023-510098-33-00', 'type': 'REGISTRY', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab, AZD0486 - A', 'description': 'AZD0486 regimen A plus rituximab', 'interventionNames': ['Drug: AZD0486']}, {'type': 'EXPERIMENTAL', 'label': 'Rituximab, AZD0486 - B', 'description': 'AZD0486 regimen B plus rituximab', 'interventionNames': ['Drug: AZD0486']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemoimmunotherapy', 'description': "Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP or R-CVP followed by rituximab maintenance, or B-R followed by rituximab maintenance)", 'interventionNames': ['Drug: R-CHOP', 'Drug: R-CVP', 'Drug: BR']}], 'interventions': [{'name': 'AZD0486', 'type': 'DRUG', 'description': 'a fully human bispecific monoclonal IgG4 antibody', 'armGroupLabels': ['Rituximab, AZD0486 - A', 'Rituximab, AZD0486 - B']}, {'name': 'R-CHOP', 'type': 'DRUG', 'description': 'Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone', 'armGroupLabels': ['Chemoimmunotherapy']}, {'name': 'R-CVP', 'type': 'DRUG', 'description': 'Rituximab, Cyclophosphamide, Vincristine and Prednisone', 'armGroupLabels': ['Chemoimmunotherapy']}, {'name': 'BR', 'type': 'DRUG', 'description': 'Bendamustine, Rituximab', 'armGroupLabels': ['Chemoimmunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Garran', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '3084', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '2109', 'city': 'Macquarie University', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Research Site'}, {'zip': '6009', 'city': 'Nedlands', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '1070', 'city': 'Brussels', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'status': 'NOT_YET_RECRUITING', 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