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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03268954




Registration number
NCT03268954
Ethics application status
Date submitted
30/08/2017
Date registered
31/08/2017
Date last updated
28/10/2024

Titles & IDs
Public title
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
Scientific title
A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
Secondary ID [1] 0 0
2017-000318-40
Secondary ID [2] 0 0
Pevonedistat-3001
Universal Trial Number (UTN)
Trial acronym
PANTHER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndrome 0 0
Leukemia, Myelomonocytic, Chronic 0 0
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Azacitidine
Treatment: Drugs - Pevonedistat

Experimental: Azacitidine 75 mg/m^2 - Azacitidine 75 milligram per square meter (mg/m\^2) intravenous (IV) or subcutaneous (SC) injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to approximately 42 months.

Experimental: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 - Azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to approximately 42 months.


Treatment: Drugs: Azacitidine
Azacitidine intravenous or subcutaneous formulation.

Treatment: Drugs: Pevonedistat
Pevonedistat intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS)
Timepoint [1] 0 0
From randomization until transformation to acute myeloid leukemia, or death due to any cause up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [2] 0 0
Kaplan-Meier Estimates of Six-Month Survival Rate
Timepoint [2] 0 0
Up to Month 6
Secondary outcome [3] 0 0
Kaplan-Meier Estimates of One-Year Survival Rate
Timepoint [3] 0 0
Up to Year 1
Secondary outcome [4] 0 0
Thirty-Day Mortality Reported as Number of Participants Who Died Up to Day 30
Timepoint [4] 0 0
Up to Day 30
Secondary outcome [5] 0 0
Sixty-Day Mortality Reported as Number of Participants Who Died Up to Day 60
Timepoint [5] 0 0
Up to Day 60
Secondary outcome [6] 0 0
Time to Acute Myelogenous Leukemia (AML) Transformation in Higher-Risk Myelodysplastic Syndromes (HR MDS), Higher-Risk Chronic Myelomonocytic Leukemias (HR CMML) and HR MDS/CMML Participants
Timepoint [6] 0 0
From randomization until transformation to AML till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [7] 0 0
Number of Participants With Complete Remission (CR) and CR+ Complete Remission With Incomplete Blood Count Recovery (CRi)
Timepoint [7] 0 0
From randomization until CR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [8] 0 0
Number of Participants With CR and Marrow CR
Timepoint [8] 0 0
From randomization until CR or marrow CR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [9] 0 0
Number of Participants With CR, Partial Remission (PR) and Hematologic Improvement (HI)
Timepoint [9] 0 0
From randomization until, CR, PR or HI till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [10] 0 0
Number of Participants With CR and Marrow CR and PR
Timepoint [10] 0 0
From randomization until CR or Marrow CR and PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [11] 0 0
Number of Participants With CR and Marrow CR, PR and Hematologic Improvement (HI)
Timepoint [11] 0 0
From randomization until CR, marrow CR, PR or HI till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [12] 0 0
Number of Participants With Overall Response (OR)
Timepoint [12] 0 0
From randomization until CR and PR or CR, CRi and PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [13] 0 0
Number of Participants With Overall Response 2 (OR2)
Timepoint [13] 0 0
From randomization until, CR, PR or HI or CR, CRi or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [14] 0 0
Duration of Complete Remission (CR)
Timepoint [14] 0 0
From CR until first documentation of PD or relapse from CR or relapse after CR or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [15] 0 0
Duration of Complete Remission + Complete Remission With Incomplete Blood Count Recovery (CRi)
Timepoint [15] 0 0
From CR until first documentation of PD or relapse from CR or relapse after CR or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [16] 0 0
Duration of Overall Response (OR)
Timepoint [16] 0 0
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [17] 0 0
Duration of Overall Response 2 (OR2)
Timepoint [17] 0 0
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [18] 0 0
Percentage of Participants With Red Blood Cells (RBCs) and Platelet-transfusion Independence
Timepoint [18] 0 0
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [19] 0 0
Duration of Red Blood Cells (RBCs) and Duration of Platelet-transfusion Independence and Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence
Timepoint [19] 0 0
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [20] 0 0
Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
Timepoint [20] 0 0
From randomization until CR or PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [21] 0 0
Number of Participants With Hematologic Improvement (HI)
Timepoint [21] 0 0
From randomization until HI till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [22] 0 0
Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML
Timepoint [22] 0 0
From randomization until transformation to AML or until initiation of subsequent therapy till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [23] 0 0
Time to Progressive Disease (PD), Relapse After CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death
Timepoint [23] 0 0
From randomization until PD, relapse after CR, or relapse after CR or PR, or death due to any cause, whichever occurs first till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [24] 0 0
Health-Related Quality of Life (HRQOL) Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30
Timepoint [24] 0 0
Up to data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [25] 0 0
Plasma Concentration of Pevonedistat
Timepoint [25] 0 0
Cycle 1 Day 1 predose and multiple time points (up to 4 hours) post dose; Cycle 1 Days 3 and 5 predose; Cycle 2 and 4 Day 1 at multiple time points (up to 3 hours) post dose; Cycle 4 Day 3 predose (Cycle length= 28 days)
Secondary outcome [26] 0 0
Number of Participants With Overall Response in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Timepoint [26] 0 0
From randomization until CR, CRi and PR till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [27] 0 0
Event-Free Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Timepoint [27] 0 0
From randomization until transformation to AML if eligible or death till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [28] 0 0
Overall Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
Timepoint [28] 0 0
From randomization until death till data cut-off date: 28 May 2021 (up to approximately 42 months)
Secondary outcome [29] 0 0
Number of Participants With Overall Response by Cycle 6
Timepoint [29] 0 0
Up to Cycle 6 (up to approximately Day 168)

Eligibility
Key inclusion criteria
1. Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or CMML (i.e., with white blood cell [WBC] <13,000/microliter [mcL]) or low-blast acute myelogenous leukemia (AML).
2. Has MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R):

* Very high (>6 points).
* High (>4.5-6 points).
* Intermediate (>3-4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of >=5% bone marrow myeloblasts.
3. Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.
4. Participants with AML (20%-30% blasts) must have a treatment-related mortality (TRM) score >=4 for intensive, induction chemotherapy as calculated using the simplified model described by Walter and coworkers.

Calculation of TRM score:

* 0 for (age <61 years), +2 for (age 61-70 years), +4 for (age >=71 years).
* + 0 for (PS=0), +2 for (PS=1), +4 for (PS >1).
* + 0 for (platelets <50), +1 for (platelets >=50).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has previous treatment for HR MDS or CMML or low-blast AML with chemotherapy or other antineoplastic agents including hypomethylating agent (HMAs) such as decitabine or azacitidine. Previous treatment is permitted with hydroxyurea and with lenalidomide, except that lenalidomide may not be given within 8 weeks before the first dose of study drug.
2. Has acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis.
3. Participants with AML with a WBC count >50,000/mcL. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria.
4. Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation. The reason a participant is not eligible for intensive chemotherapy and/or allogeneic stem cell transplantation may consist of one or more of the following factors:

* Age >75.
* Comorbidities.
* Inability to tolerate intensive chemotherapy (e.g., participants with AML with 20%-30% blasts and TRM >=4).
* Physician decision (e.g., lack of available stem cell donor).
* The reason a participant is not eligible should be documented in the electronic case report form (eCRF).
5. Has either clinical evidence of or history of central nervous system involvement by AML.
6. Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
7. Is diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease.
8. Has nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.
9. Has prothrombin time (PT) or aPTT >1.5× upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment.
10. Has known human immunodeficiency virus (HIV) seropositive.
11. Has known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.
12. Has known hepatic cirrhosis or severe preexisting hepatic impairment.
13. Has known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), and/or myocardial infarction within 6 months before first dose, or severe pulmonary hypertension.
14. Has treatment with strong cytochrome P 3A (CYP3A) inducers within 14 days before the first dose of pevonedistat.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2024
Sample size
Target
Accrual to date
Final
454
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment hospital [1] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [2] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [3] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [4] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [5] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
1871 - Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
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Missouri
Country [12] 0 0
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State/province [12] 0 0
Nebraska
Country [13] 0 0
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New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerpen
Country [23] 0 0
Belgium
State/province [23] 0 0
Namur
Country [24] 0 0
Belgium
State/province [24] 0 0
West-Vlaanderen
Country [25] 0 0
Belgium
State/province [25] 0 0
Bruxelles
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Brazil
State/province [27] 0 0
Parana
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio Grande Do Norte
Country [29] 0 0
Brazil
State/province [29] 0 0
Santa Catarina
Country [30] 0 0
Brazil
State/province [30] 0 0
Porto Alegre
Country [31] 0 0
Brazil
State/province [31] 0 0
Rio De Janeiro
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Paulo
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
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New Brunswick
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
China
State/province [36] 0 0
Beijing
Country [37] 0 0
China
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Tianjin
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Czechia
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Kralovehradeck Kraj
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Czechia
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Prague
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Czechia
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Praha
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France
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Calvados
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France
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Maine-et-Loire
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France
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Le Mans
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France
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Paris
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Germany
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Baden-Wurttemberg
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Germany
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Sachsen
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Germany
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Dresden
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Germany
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Dusseldorf
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Greece
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Attiki
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Greece
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Alexandroupolis
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Patras
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Greece
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Thessaloniki
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Israel
State/province [56] 0 0
Holon
Country [57] 0 0
Israel
State/province [57] 0 0
Jerusalem
Country [58] 0 0
Israel
State/province [58] 0 0
Nahariya
Country [59] 0 0
Israel
State/province [59] 0 0
Safed
Country [60] 0 0
Israel
State/province [60] 0 0
Tel Aviv
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Firenze
Country [64] 0 0
Italy
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Rionero in Vulture
Country [65] 0 0
Italy
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Rozzano
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Italy
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Torino
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Japan
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Hirosima
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Japan
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Hokkaido
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Japan
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Hukusima
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Japan
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Hyogo
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Fukuoka-city
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Japan
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Mibu
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Japan
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Nagasaki
Country [78] 0 0
Japan
State/province [78] 0 0
Yokohama-shi
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Japan
State/province [79] 0 0
Yoshida-gun
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Korea, Republic of
State/province [80] 0 0
Busan
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Daegu
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Jeongnam
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Seoul
Country [84] 0 0
Mexico
State/province [84] 0 0
Huixquilucan
Country [85] 0 0
Mexico
State/province [85] 0 0
Mexico
Country [86] 0 0
Poland
State/province [86] 0 0
Mazowieckie
Country [87] 0 0
Poland
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Pomorskie
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Poland
State/province [88] 0 0
Swietokrzyskie
Country [89] 0 0
Poland
State/province [89] 0 0
Lublin
Country [90] 0 0
Poland
State/province [90] 0 0
Opole
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Moscow
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Saint Petersburg
Country [93] 0 0
Russian Federation
State/province [93] 0 0
St. Petersburg
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Castilla Y Leon
Country [96] 0 0
Spain
State/province [96] 0 0
Madrid
Country [97] 0 0
Spain
State/province [97] 0 0
Salamanca
Country [98] 0 0
Spain
State/province [98] 0 0
Valencia
Country [99] 0 0
Turkey
State/province [99] 0 0
Ankara
Country [100] 0 0
Turkey
State/province [100] 0 0
Izmir
Country [101] 0 0
Turkey
State/province [101] 0 0
Mersin
Country [102] 0 0
Turkey
State/province [102] 0 0
Samsun
Country [103] 0 0
Turkey
State/province [103] 0 0
Tekirdag
Country [104] 0 0
Turkey
State/province [104] 0 0
Trabzon
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Dorset
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Kent
Country [107] 0 0
United Kingdom
State/province [107] 0 0
London
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Takeda Development Center Americas, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
Trial website
https://clinicaltrials.gov/study/NCT03268954
Trial related presentations / publications
Ades L, Girshova L, Doronin VA, Diez-Campelo M, Valcarcel D, Kambhampati S, Viniou NA, Woszczyk D, De Paz Arias R, Symeonidis A, Anagnostopoulos A, Munhoz EC, Platzbecker U, Santini V, Fram RJ, Yuan Y, Friedlander S, Faller DV, Sekeres MA. Pevonedistat plus azacitidine vs azacitidine alone in higher-risk MDS/chronic myelomonocytic leukemia or low-blast-percentage AML. Blood Adv. 2022 Sep 13;6(17):5132-5145. doi: 10.1182/bloodadvances.2022007334.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03268954