A trial to learn if AZD0486 alone or with other anticancer drugs is safe and works in adults with certain blood cancers

Start 5 Mar 2025 · Status Ongoing, recruiting · 5 EU/EEA countries · 21 sites · Protocol D7407C00001

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ongoing, recruiting

Participants planned 446

Countries 5

Sites 21

Mantle Cell Lymphoma

To assess safety and tolerability and determine the RP2D (recommended Phase II dose) of AZD0486 (administered as IV or SC) as monotherapy and in combination with other anticancer agents across mature B-cell malignancies

Key facts

Sponsor: AstraZeneca AB
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 5 Mar 2025 → ongoing
Decision date (initial): 2025-01-08
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-515034-33-00
ClinicalTrials.gov: NCT06564038

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy, Dose response, Pharmacokinetic

Conditions and MedDRA coding

Mantle Cell Lymphoma

Version	Level	Code	Term	System organ class
20.0	PT	10061275	Mantle cell lymphoma	100000004864
21.0	LLT	10051812	Small cell lymphocytic lymphoma	10029104
21.0	PT	10012818	Diffuse large B-cell lymphoma	100000004864
21.1	PT	10008958	Chronic lymphocytic leukaemia	100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 22

All sub- studies: Age ≥ 18 years
Sub-study 3: LVEF >50%
All sub- studies: ECOG performance status 0 to 2
Sub-study 3: Contraception until x days after the last dose of AZD0486, 4 months after the last dose of vincristine, and 6 months after the last dose of cyclophosphamide or doxorubicin, (or as required by local prescribing information) whichever is longer.
All sub-studies: Contraception during treatment and at least x days after final dose
All sub- studies: Confirmed CD19 expression if prior anti-CD19 therapy
Sub-study 1: CLL/SLL diagnosis and meets iwCLL criteria for treatment
Sub-study 1: SLL: at least 1 measurable site per Lugano
Sub-study 1: Absolute lymphocytes <10,000
Sub-study 1, Cohort 1A and Cohort 1C: at least 2 prior lines of systemic therapy for CLL/SLL
Sub-study 1, Cohort 1B: at least 1 prior line of therapy and BTKi sensitive or naïve
Sub-study 2: MCL diagnosis per WHO
Sub-study 3: Absolute lymphocytes count of < 5 × 109 cells/L
Sub-study 3: Haemoglobin ≥ 9 g/dL
Sub-study 2: Clinical Stage II, III, or IV per Ann Arbor classification
Sub-study 2: At least 1 measurable site per Lugano
Sub-study 2: ALC < 10,000
Sub- study 2, Cohort 2A and Cohort 2C: Relapsed or Progressed after 2 or more prior systemic therapy for MCL including BTKi
Sub-study 3: Large B-cell lymphoma per WHO 2022 or R/R B-NHL after at least 1 prior line of therapy
Sub-study 3: IPI 2-5 for participants with untreated LBCL diagnoses
Sub-study 3: At least 1 measurable site as per Lugano
Sub-study 1: Contraception during treatment and until at least x days after the last dose of AZD0486 and until 2 days after the last dose of acalabrutinib, whichever is longer.

Exclusion criteria 14

All sub- studies: CNS lymphoma
Sub-study 1, Cohort 1B: bleeding diathesis, treatment with strong CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist
Sub-study 2 Exclusion Criteria Refer to Section 5.2 of the Master Protocol.
Sub-study 3: Mediastinal grey-zone lymphoma, Burkitt, Richter’s transformation, primary effusion LBCL
Sub-study 3: Cumulative dose of anthracycline ≥ 150 mg/m2
All sub- studies: Major Surgical procedure within 14 days before the first dose of study drug
All sub- studies: Clinically significant CV disease
All sub- studies: Unresolved non-haematological Grade ≥ 2 AEs (NCI CTCAE V5.0) from prior anticancer therapy (except alopecia or fatigue)
All sub-studies: Any anticancer systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to Cycle 1 Day 1
All sub-studies: Radiation therapy within 28 days of Cycle 1 Day 1
All sub-studies: Prior CAR-T therapy or auto-HSCT within 12 weeks or prior TCE within 8 weeks of Cycle 1 Day 1
All sub-studies: Prior Grade ≥ 3 CRS or ICANS event
Sub-study 1: CLL transformation to more aggressive lymphoma
All sub-studies: Active, significant, or uncontrolled infection or autoimmune disease requiring systemic therapy which places participant at unacceptable risk if he/she were to participate in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

Incidence, nature and severity of AEs/SAEs based on NCI CTCAE v5.0/ASTCT criteria; changes in laboratory data, and vital signs compared with baseline
Incidence of Dose Limiting Toxicity (DLTs)
Incidence and severity of AESIs
Incidence and nature of study drug discontinuation, dose reduction and dose delay due to AEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

AZD0486

PRD11433842 · Product

Active substance: Human IGG4 Kappa Monoclonal Antibody Against CD3 and CD19
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Authorisation status: Not Authorised
MA holder: ASTRAZENECA AB
Paediatric formulation: No
Orphan designation: No

AZD0486

PRD10472872 · Product

Active substance: Human IGG4 Kappa Monoclonal Antibody Against CD3 and CD19
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Authorisation status: Not Authorised
MA holder: ASTRAZENECA AB
Paediatric formulation: No
Orphan designation: No

AZD0486

PRD12392694 · Product

Active substance: Surovatamig
Substance synonyms: Human IgG4 kappa monoclonal antibody against CD3 and CD19, TNB-486, AZD0486
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Authorisation status: Not Authorised
MA holder: ASTRAZENECA AB
Paediatric formulation: No
Orphan designation: No

AZD0486

PRD12392695 · Product

Active substance: Surovatamig
Substance synonyms: Human IgG4 kappa monoclonal antibody against CD3 and CD19, TNB-486, AZD0486
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Authorisation status: Not Authorised
MA holder: ASTRAZENECA AB
Paediatric formulation: No
Orphan designation: No

Comparator 9

Vinorelbine

SCP1137788 · ATC

Active substance: Vinorelbine
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01CA02 — VINCRISTINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Labelling, for AstraZeneca supplied product.

Cyclophosphamide

SCP106382672 · ATC

Active substance: Cyclophosphamide
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Labelling, for AstraZeneca supplied product.

Rituximab

SCP872361 · ATC

Active substance: Rituximab
Substance synonyms: CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01FA01 — RITUXIMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Labelling, for AstraZeneca supplied product.

Rituximab

SCP24437829 · ATC

Active substance: Rituximab
Substance synonyms: CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01XC02 — RITUXIMAB
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Labelling, for AstraZeneca supplied product.

Betamethasone Sodium Phosphate

SCP107974752 · ATC

Active substance: Betamethasone Sodium Phosphate
Substance synonyms: BETAMETHASONE DISODIUM PHOSPHATE
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: H02AB06 — PREDNISOLONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisolone

SCP107216203 · ATC

Active substance: Prednisolone
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: H02AB07 — PREDNISONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Labelling, for AstraZeneca supplied product.

Calquence 100 mg film-coated tablets

PRD10242588 · Product

Active substance: Acalabrutinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: L01EL02 — -
Marketing authorisation: EU/1/20/1479/004
MA holder: ASTRAZENECA AB
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The clinical supply is provided in HDPE bottles (rather than blisters in MAA) and has different manufacturing sites for this clinical supply chain

Calquence 100 mg film-coated tablets

PRD10242587 · Product

Active substance: Acalabrutinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: L01EL02 — -
Marketing authorisation: EU/1/20/1479/003
MA holder: ASTRAZENECA AB
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: The clinical supply is provided in HDPE bottles (rather than blisters in MAA) and has different manufacturing sites for this clinical supply chain

Doxorubicin Hydrochloride

SCP138158 · ATC

Active substance: Doxorubicin Hydrochloride
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: L01DB01 — DOXORUBICIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Labelling, for AstraZeneca supplied product.

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation: AstraZeneca AB
Address: -
City: Sodertalje
Postcode: 151 85
Country: Sweden

Scientific contact point

Organisation: AstraZeneca AB
Contact name: AstraZeneca Clinical Study Information Center

Public contact point

Organisation: AstraZeneca AB
Contact name: AstraZeneca Clinical Study Information Center

Third parties 1

Organisation	City, country	Duties
Parexel International (IRL) Limited ORG-100022780	Dublin 2, Ireland	On site monitoring, Code 10, Code 11, Code 12, Code 14, Code 2, Code 5, Data management, E-data capture, Code 8, Code 9

Locations

5 EU/EEA countries · 21 investigational sites

By country

Country	MS status	Planned subjects	Sites
Czechia	Ongoing, recruiting	32	3
Denmark	Ongoing, recruiting	38	4
France	Ongoing, recruiting	36	4
Germany	Ongoing, recruiting	42	4
Spain	Ongoing, recruiting	52	6
Rest of world United States, United Kingdom, Korea, Republic of, Taiwan, Japan, China, Australia	—	246	—

Investigational sites

Czechia

3 sites · Ongoing, recruiting

Vseobecna Fakultni Nemocnice V Praze

1902:I. Interni klinika - klinika hematologie VFN a 1. LF UK v Praze, U Nemocnice 499/2, Nove Mesto, Prague

Institute Of Hematology And Blood Transfusion

1903:Oddělení buněčné terapie, U Nemocnice 2094/1, Nove Mesto, Prague

Fakultni Nemocnice Ostrava

1901:Klinika plicnich nemoci a TBC, 17. Listopadu 1790/5, Poruba, Ostrava

Denmark

4 sites · Ongoing, recruiting

Region Midtjylland

2001:Department of Haematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Rigshospitalet

2002:Department of Haematology and Phase 1 Unit., Blegdamsvej 9, 2100, Copenhagen Oe

Aalborg University Hospital

2003:Department of Haematology, Hobrovej 18-22, 9000, Aalborg

Odense University Hospital

2004: Oncology, J. B. Winsloews Vej 4, 5000, Odense C

France

4 sites · Ongoing, recruiting

Centre Hospitalier Universitaire De Montpellier

2301: Hématologie clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Hopital Saint Louis

2303: Service d’Hémato-oncologie, 1 Avenue Claude Vellefaux, 75010, Paris

Institut Curie

2302: Oncology, 35 Rue Dailly, 92210, Saint-Cloud

Institut Gustave Roussy

2304: Département d’Innovations Thérapeutiques et d’essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif

Germany

4 sites · Ongoing, recruiting

Universitaetsklinikum Wuerzburg AöR

2601:Med. Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg

Klinikum der Universitaet Muenchen AöR

2602:Hemat/Transfusion Med, Marchioninistrasse 15, Hadern, Munich

Universitaetsklinikum Schleswig-Holstein AöR

2603:Medizinische Klinik II, Arnold-Heller-Strasse 3, Brunswik, Kiel

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

2604: Schwerpunkt Endokrinologie, Langenbeckstrasse 1, Oberstadt, Mainz

Spain

6 sites · Ongoing, recruiting

University Hospital Son Espases

7002: Hematologia, Carretera Valldemossa 79, 07120, Palma

Hospital Universitario Y Politecnico La Fe

7005: Hematología, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Hospital Clinic De Barcelona

7004: Hematología, Calle Villarroel 170, 08036, Barcelona

Hospital Universitario Fundacion Jimenez Diaz

7001: Hematología y Hemoterapia, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital Universitario Ramon Y Cajal

7006: Hematología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid

Complexo Hospitalario Universitario De Santiago

7003: Hematología, Calle Choupana Da S/n, 15706, Santiago De Compostela

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
Czechia	2025-03-28	2025-04-10
Denmark	2025-03-21	2025-04-08
France	2025-05-02	2025-06-12
Germany	2025-07-02	2025-07-31
Spain	2025-03-05	2025-04-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 115 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol Main English D7407C00001 Public	3.0/1.0 EU
Protocol (for publication)	D1_Protocol Substudy_1 English D7407C00001 Public	3.0/1.0 EU
Protocol (for publication)	D1_Protocol Substudy_2 English D7407C00001 Public	3.0
Protocol (for publication)	D1_Protocol Substudy_3 English D7407C00001 Public	3.0
Recruitment arrangements (for publication)	K1_CZE Country ICF Procedure Czech D7407C00001 Public	1.0
Recruitment arrangements (for publication)	K1_DEU Recruitment Procedure Description English D7407C00001 Public	1.0
Recruitment arrangements (for publication)	K1_DNK Recruitment Procedure Description English D7407C00001 Public	1.2
Recruitment arrangements (for publication)	K1_ESP Country ICF Procedure English D7407C00001 Public	1.0
Recruitment arrangements (for publication)	K1_FRA Recruitment Procedure Description French D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Genetic Research already enrolled Czech D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Genetic Research Czech D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 1A Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 1A enrolled Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 1B Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 1B enrolled Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 1C Czech D7407C00001 Public	1.1
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 2A Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 2A enrolled Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 2C Czech D7407C00001 Public	1.1
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 3 Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Main part 3 enrolled Czech D7407C00001 Public	4.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Other Optional procedures Czech D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Other Pregnant Partner part 1 Czech D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Other Pregnant Partner part 2 Czech D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Other Pregnant Partner part 3 Czech D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Privacy Czech D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Research already enrolled Czech D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_CZE Country ICF Research Czech D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_CZE Subject Participation Card Czech D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Main Substudy 1-Cohort 1A German D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Main Substudy 1-Cohort 1B German D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Main Substudy 1-Cohort 1C German D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Main Substudy 1-Cohort 2C German D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Main Substudy 2-Cohort 2A German D7407C00001 Public	3.1
Subject information and informed consent form (for publication)	L1_DEU Country ICF Main Substudy 3 German D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Other Country Optional Genomics German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Other Pregnant Partner-Participant Substudy 1 German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Other Pregnant Partner-Participant Substudy 2 German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Other Pregnant Partner-Participant Substudy 3 German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Procedure English D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Research Substudy 1-Cohort 1A German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Research Substudy 1-Cohort 1B German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Research Substudy 1-Cohort 1C German D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Research Substudy 1-Cohort 2C German D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Research Substudy 2-Cohort 2A German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DEU Country ICF Research Substudy 3 German D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Addendum Cohort 1A Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Addendum Cohort 1B Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Addendum Cohort 2A Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Addendum Substudy 3 Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Addendum Cohort 1C Danish D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Addendum Cohort 2C Danish D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Main Cohort 1A Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Main Cohort 1B Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Main Cohort 1C Danish D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Main Cohort 2A Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Main Cohort 2C Danish D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Main Substudy 3 Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Other Pregnancy FU Substudy 1 Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Other Pregnancy FU Substudy 2 Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Other Pregnancy FU Substudy 3 Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_DNK Country ICF Procedure English D7407C00001 Public	1.1
Subject information and informed consent form (for publication)	L1_DNK Country ICF Research Danish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Genetic Research Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Main Cohort 1A Spanish D7407C00001 Public	2.1
Subject information and informed consent form (for publication)	L1_ESP Country ICF Main Cohort 1B Spanish D7407C00001 Public	2.1
Subject information and informed consent form (for publication)	L1_ESP Country ICF Main Cohort 1C Spanish D7407C00001 Public	1.1
Subject information and informed consent form (for publication)	L1_ESP Country ICF Main Cohort 2A Spanish D7407C00001 Public	2.1
Subject information and informed consent form (for publication)	L1_ESP Country ICF Main Cohort 2C Spanish D7407C00001 Public	1.1
Subject information and informed consent form (for publication)	L1_ESP Country ICF Main Cohort 3 Spanish D7407C00001 Public	2.1
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Future Research Cohorte 1C Spanish D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Future Research Cohorte 2C Spanish D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Future Research ICF Cohort 1A Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Future Research ICF Cohort 1B Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Future Research ICF Cohort 2A Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Future Research ICF Cohort 3 Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Pregnant Partner ICF Sub-study 1 Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Pregnant Partner ICF Sub-study 2 Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_ESP Country ICF Other Pregnant Partner ICF Sub-study 3 Spanish D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Genetic Research French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Main Substudy 1-Cohort 1B French D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Main Substudy 2-Cohort 2A French D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Main Substudy 3 French D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Main Substudy 1-Cohort 1A French D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Main Substudy 1-Cohort 1C French D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Main Substudy 2-Cohort 2C French D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Other Pregnant Partner Substudy 1 French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Other Pregnant Partner Substudy 2 French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Other Pregnant Partner Substudy 3 French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Research Substudy 1-Cohort 1A French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Research Substudy 1-Cohort 1B French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Research Substudy 2-Cohort 2A French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Research Substudy 3 French D7407C00001 Public	2.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Research Substudy 1-Cohort 1C French D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L1_FRA Country ICF Research Substudy 2-Cohort 2C French D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L2_DNK Subject Materials_Dine rettigheder som forsgsperson Danish D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L2_FRA Subject Information Sheet Glossary Cohort 1A French D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L2_FRA Subject Information Sheet Glossary Cohort 1B French D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L2_FRA Subject Information Sheet Glossary Cohort 1C French D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L2_FRA Subject Information Sheet Glossary Cohort 2A French D7407C00001 Public	3.0
Subject information and informed consent form (for publication)	L2_FRA Subject Information Sheet Glossary Cohort 2C French D7407C00001 Public	1.0
Subject information and informed consent form (for publication)	L2_FRA Subject Information Sheet Glossary-Substudy 3 French D7407C00001 Public	2.0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Rituximab L01XC02 D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Acalabrutinib D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Cyclophosphamide D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Doxorubicin D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Prednisolone D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Prednisone D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Rituximab L01FA01 D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Rituximab L01FA01 D7407C00001 Public	NA
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Vincristine D7407C00001 Public	NA
Synopsis of the protocol (for publication)	D1_Lay Protocol Synopsis Main Czech D7407C00001 Public	3.0
Synopsis of the protocol (for publication)	D1_Lay Protocol Synopsis Main English D7407C00001 Public	3.0
Synopsis of the protocol (for publication)	D1_Lay Protocol Synopsis Main French D7407C00001 Public	3.0
Synopsis of the protocol (for publication)	D1_Lay Protocol Synopsis Main Spanish D7407C00001 Public	3.0

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-08-29	Spain	Acceptable with conditions 2025-01-07	2025-01-07
2	SUBSTANTIAL MODIFICATION	SM-1	2025-01-21		Acceptable with conditions	2025-03-12
3	SUBSTANTIAL MODIFICATION	SM-2	2025-07-08	Spain	Acceptable 2025-10-09	2025-10-09
4	SUBSTANTIAL MODIFICATION	SM-3	2025-10-31		Acceptable	2025-11-25

A trial to learn if AZD0486 alone or with other anticancer drugs is safe and works in adults with certain blood cancers

Overview

Key facts

External identifiers

Trial design

Main objective

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 22

Exclusion criteria 14

Endpoints

Primary endpoints 4

Investigational products

Test 4

Comparator 9

Sponsors and contacts

AstraZeneca AB

Scientific contact point

Public contact point

Third parties 1

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 115 files

Application history

Related clinical trials