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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04401748
Registration number
NCT04401748
Ethics application status
Date submitted
22/05/2020
Date registered
26/05/2020
Date last updated
24/05/2024
Titles & IDs
Public title
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
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Scientific title
A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)
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Secondary ID [1]
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2023-507153-16-00
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Secondary ID [2]
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M15-954
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Universal Trial Number (UTN)
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Trial acronym
Verona
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndrome (MDS)
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Treatment: Drugs - Azacitidine
Treatment: Drugs - Placebo
Experimental: Arm 1: Venetoclax + Azacitidine (AZA) - Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
Active Comparator: Arm 2: Placebo + Azacitidine - Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
Treatment: Drugs: Venetoclax
Tablet: Oral
Treatment: Drugs: Azacitidine
Subcutaneous (SC) or Intravenous (IV) injection
Treatment: Drugs: Placebo
Tablet; Oral
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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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Overall survival (OS)
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Assessment method [1]
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OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.
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Timepoint [1]
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Up To 5 Years
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Secondary outcome [1]
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Modified Overall Response (mOR)
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Assessment method [1]
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mOR [complete remission (CR) + marrow complete remission (mCR) + partial response (PR)] is defined as achieving a CR, mCR, or PR at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
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Timepoint [1]
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Up To 5 Years
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Secondary outcome [2]
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Percentage of Participants Achieving Overall Hematological Improvement (HI)
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Assessment method [2]
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Overall HI is defined as achieving the response of HI-platelet or HI-neutrophil, or HI-erythroid at any time point during the study prior to post-treatment therapy per the modified IWG 2006 criteria for MDS.
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Timepoint [2]
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Up to 5 Years
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Secondary outcome [3]
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Complete Remission (CR)
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Assessment method [3]
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CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
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Timepoint [3]
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Up To 36 Months
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Secondary outcome [4]
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Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline
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Assessment method [4]
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TI is when the participants who were transfusion dependent on red blood cell (RBC) and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, or 1 day before the date of progressive disease/ relapse from CR or PR per the modified IWG 2006 criteria for MDS, or 1 day before the initiation of post-treatment therapy or 1 day before death, whichever is earliest.
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Timepoint [4]
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Up To 5 Years
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Secondary outcome [5]
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Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale
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Assessment method [5]
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Time to deterioration in physical functioning, as measured by the EORTC QLQ-C30 physical functioning score is defined as the time from the date of randomization to the date of death of any cause, or the first time worsening of score from baseline >= a pre-specified threshold. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
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Timepoint [5]
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Up To 5 Years
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Secondary outcome [6]
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score
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Assessment method [6]
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Fatigue will be assessed using the PROMIS Fatigue SF 7a Global Fatigue Score. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".
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Timepoint [6]
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Up To 5 Years
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Secondary outcome [7]
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Overall Response (OR)
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Assessment method [7]
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OR [complete remission (CR) + partial response (PR)] is defined as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.
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Timepoint [7]
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Up To 5 Years
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Eligibility
Key inclusion criteria
- Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016
World Health Organization (WHO) classification wtih presence of < 20% bone marrow
blasts per marrow biopsy/aspirate at screening.
- Participants must meet the following disease activity criteria:
- Overall Revised International Prognostic Scoring System (IPSS-R) score > 3
(intermediate, high or very high).
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
- Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at
the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of
Study Day 1.
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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
- Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem
cell transplantation.
- Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing
myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia
(CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia
(JMML) and unclassifiable MDS/MPN.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
10/09/2020
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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
10/09/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
531
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Duplicate_Blacktown Hospital /ID# 234079 - Blacktown
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Recruitment hospital [2]
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St George Hospital /ID# 221810 - Kogarah
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Port Macquarie Base Hospital /ID# 234078 - Port Macquarie
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Gold coast University Hospital /ID# 222606 - SouthPort
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Royal Adelaide Hospital /ID# 221805 - Adelaide
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St Vincent's Hospital Melbourne /ID# 221809 - Fitzroy Melbourne
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Recruitment hospital [7]
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Austin Health /ID# 221807 - Heidelberg
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2148 - Blacktown
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2217 - Kogarah
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2444 - Port Macquarie
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4215 - SouthPort
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5000 - Adelaide
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3065 - Fitzroy Melbourne
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Recruitment postcode(s) [7]
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3084 - Heidelberg
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Recruitment outside Australia
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Eindhoven
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Netherlands
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Enschede
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Maastricht
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Rotterdam
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Zwolle
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Kujawsko-pomorskie
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Lodzkie
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Lubelskie
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Mazowieckie
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Pomorskie
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Poland
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Katowice
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Puerto Rico
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Curitiba
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Rio Piedras
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San Juan
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Russian Federation
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Kaluzhskaya Oblast
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Russian Federation
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Stavropol Skiy Kray
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Russian Federation
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Moscow
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Russian Federation
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Petrozavodsk
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Russian Federation
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Sankt-Peterburg
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Turkey
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Kayseri
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Samsun
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Turkey
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Tuzla
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United Kingdom
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Bristol, City Of
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United Kingdom
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Devon
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United Kingdom
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Dorset
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United Kingdom
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Oxfordshire
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United Kingdom
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Wales
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United Kingdom
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Aberdeen
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United Kingdom
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Birmingham
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Genentech, Inc.
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Ethics approval
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Summary
Brief summary
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a
person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce
normal blood cells. Some people with MDS have a risk of the disease progressing to acute
myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include
fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy
or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of
this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are
when compared to AZA and a placebo (contains no medicine), in participants with newly
diagnosed higher-risk MDS.
Venetoclax is an investigational drug being developed for the treatment of MDS. The study
consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In
another arm, participants will receive AZA and placebo. Adult participants with newly
diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in
approximately 220 sites worldwide.
Participants in one arm will receive oral doses of venetoclax tablet and intravenous
(infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in
another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA
solution.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the course of the study at a
hospital or clinic. The effect of the treatment will be checked by medical assessments, blood
and bone marrow tests, checking for side effects, and completing questionnaires.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04401748
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04401748
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