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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06564038
Registration number
NCT06564038
Ethics application status
Date submitted
19/08/2024
Date registered
21/08/2024
Date last updated
8/09/2025
Titles & IDs
Public title
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
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Scientific title
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
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Secondary ID [1]
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2024-515034-33-00
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Secondary ID [2]
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D7407C00001
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Universal Trial Number (UTN)
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Trial acronym
Soundtrack-E
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukaemia
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Small Lymphocytic Lymphoma
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Mantle-cell Lymphoma
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Large B-cell Lymphoma
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B-cell Non-Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD0486
Treatment: Drugs - Prednisone (or equivalent)
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Vincristine
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Acalabrutinib
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1A (AZD0486 Monotherapy) - Participants will receive AZD0486 monotherapy as subcutaneous (SC) injection.
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1B (AZD0486 + Acalabrutinib) - Participants will receive AZD0486 as SC injection. Participants will receive acalabrutinib tablet orally twice daily.
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1C (AZD0486 Monotherapy) - Participants will receive AZD0486 monotherapy as intravenous (IV) infusion.
Experimental: Substudy 2 (RR MCL): Cohort 2A (AZD0486 Monotherapy) - Participants will receive AZD0486 monotherapy as SC injection.
Experimental: Substudy 2 (RR MCL): Cohort 2C (AZD0486 Monotherapy) - Participants will receive AZD0486 monotherapy as IV infusion.
Experimental: Substudy 3 (LBCL): AZD0486 + R-CHOP - Participants will receive AZD0486 as IV infusion in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Treatment: Drugs: AZD0486
AZD0486 will be administered as either SC injection or IV infusion.
Treatment: Drugs: Prednisone (or equivalent)
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
Treatment: Drugs: Rituximab
Rituximab will be administered as IV infusion as per standard of care.
Treatment: Drugs: Cyclophosphamide
Cyclophosphamide will be administered as IV infusion as per standard of care.
Treatment: Drugs: Vincristine
Vincristine will be administered as IV infusion as per standard of care.
Treatment: Drugs: Doxorubicin
Doxorubicin will be administered as IV infusion as per standard of care.
Treatment: Drugs: Acalabrutinib
Acalabrutinib will be administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
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Assessment method [1]
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Safety and tolerability of AZD0486 as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
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Timepoint [1]
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Up to 6 years 4 months
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Primary outcome [2]
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Number of Participants with Dose Limiting Toxicity (DLTs)
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Assessment method [2]
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Safety and tolerability of AZD0486 as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
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Timepoint [2]
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Up to 2 months
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as percentage of participants achieving either a partial response (PR) or complete response (CR) based on response criteria for International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
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Timepoint [1]
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Up to 6 years 4 months
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Secondary outcome [2]
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Complete Response (CR) Rate
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Assessment method [2]
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CR rate is defined as percentage of participants achieving CR as best response based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
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Timepoint [2]
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Up to 6 years 4 months
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Secondary outcome [3]
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Duration of Response (DoR)
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Assessment method [3]
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DoR is defined as time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator, relapse or death (substudy 1) and time from the date of first documented response until date of documented progression based on Lugano 2014 Response Criteria by investigator assessment, relapse or death (substudies 2 and 3).
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Timepoint [3]
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Up to 6 years 4 months
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Secondary outcome [4]
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Maximum Observed Concentration (Cmax)
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Assessment method [4]
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The PK (Cmax) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [4]
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Up to 90 days after last dose
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Secondary outcome [5]
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Area Under the Concentration-time Curve (AUC)
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Assessment method [5]
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The PK (AUC) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [5]
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Up to 90 days after last dose
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Secondary outcome [6]
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Minimum Observed Concentration (Cmin)
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Assessment method [6]
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The PK (Cmin) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [6]
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Up to 90 days after last dose
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Secondary outcome [7]
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Time to Reach Maximum Concentration (Tmax)
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Assessment method [7]
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The PK (Tmax) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [7]
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Up to 90 days after last dose
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Secondary outcome [8]
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Trough Plasma Concentration (Ctrough)
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Assessment method [8]
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The PK (Ctrough) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [8]
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Up to 90 days after last dose
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Secondary outcome [9]
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Half Life (t1/2) of AZD0486
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Assessment method [9]
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The PK (t1/2) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [9]
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Up to 90 days after last dose
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Secondary outcome [10]
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Clearance (CL) of AZD0486
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Assessment method [10]
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The PK (CL) of AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [10]
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Up to 90 days after last dose
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Secondary outcome [11]
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Number of Participants with Anti-drug Antibody (ADA) for AZD0486
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Assessment method [11]
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The incidence of immunogenicity of SC AZD0486 as monotherapy and in combination with other anti-cancer agents will be evaluated.
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Timepoint [11]
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Up to 90 days after last dose
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Eligibility
Key inclusion criteria
Master Inclusion Criteria applicable to all substudies:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Contraception use during treatment and at least 90 days after final dose.
* Confirmed CD19 expression if prior anti-CD19 therapy.
Substudy 1 Specific
* Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
* SLL: at least 1 measurable site per Lugano.
* Absolute lymphocytes <10,000.
* Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
* Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.
Substudy 2 Specific
* MCL diagnosis per WHO.
* Clinical Stage II, III, or IV by Ann Arbor Classification.
* At least 1 measurable site per Lugano.
* ALC < 10,000.
* Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
Substudy 3 Specific
* Large B-cell lymphoma per WHO 2022.
* R/R B-NHL after at least 1 prior line of therapy.
* International Prognostic Index (IPI) 2-5.
* At least 1 measurable site as per Lugano.
* Left ventricular ejection fraction (LVEF) >50%.
* Contraception at least 90 days after last dose of AZD0486 or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Master Exclusion Criteria applicable to all substudies:
* Central nervous system (CNS) lymphoma.
* Surgery within 14 days of study drug.
* Clinically significant cardiovascular (CV) disease.
* Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
* Any anticancer therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
* Radiation therapy within 28 days.
* Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
* Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
* Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
Substudy 1 Specific
* CLL transformation to more aggressive lymphoma.
* Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.
Substudy 3 Specific
* Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
* Cumulative dose of anthracycline >150 mg/m2.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/04/2031
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Actual
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Sample size
Target
276
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Heidelberg
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Recruitment hospital [2]
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Research Site - Melbourne
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Recruitment hospital [3]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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Massachusetts
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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Texas
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China
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Beijing
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China
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Guangzhou
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China
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Jinan
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China
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Tianjin
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China
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Zhengzhou
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Czechia
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Ostrava - Poruba
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Czechia
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Prague
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Czechia
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Praha 2 - Nové Mesto
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Denmark
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Aalborg
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Denmark
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Aarhus N
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Denmark
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Copenhagen
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Denmark
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Odense C
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France
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Clermont-Ferrand
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France
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Montpellier
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France
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Paris
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France
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Saint-Cloud
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France
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Villejuif
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Germany
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Cologne
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Germany
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Kiel
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Germany
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München
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Germany
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Würzburg
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Japan
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Kotoku
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Japan
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Matsuyama
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Japan
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Nagoya
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South Korea
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Busan
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South Korea
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Seoul
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Santiago de Compostela
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Kaohsiung City
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Taiwan
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Tainan City
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Taiwan
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Taipei
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United Kingdom
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Derriford
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United Kingdom
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London
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United Kingdom
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State/province [47]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies.
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Trial website
https://clinicaltrials.gov/study/NCT06564038
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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 there quest portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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/NCT06564038
Download to PDF