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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/NCT04023526
Registration number
NCT04023526
Ethics application status
Date submitted
16/07/2019
Date registered
17/07/2019
Date last updated
9/08/2023
Titles & IDs
Public title
A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
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Scientific title
A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
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Secondary ID [1]
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2019-000473-23
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Secondary ID [2]
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CULM20236
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Universal Trial Number (UTN)
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Trial acronym
CULMINATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute
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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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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Azacitidine
Treatment: Drugs - Cusatuzumab
Experimental: Azacitidine 75 mg/m^2 and Cusatuzumab 10 mg/kg - Participants will receive azacitidine 75 milligram per meter square (mg/m^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee.
Experimental: Azacitidine 75 mg/m^2 and Cusatuzumab 20 mg/kg - Participants will receive azacitidine 75 mg/m^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee.
Treatment: Drugs: Azacitidine
Azacitidine SC or IV will be administered at a standard dose of 75 mg/m^2 on days 1-7 of each cycle.
Treatment: Drugs: Cusatuzumab
Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.
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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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Percentage of Participants with Complete Response (CR)
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Assessment method [1]
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Percentage of participants with complete response based on European Leukemia Network (ELN) 2017 response criteria assessment will be reported.
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Timepoint [1]
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Up to 3 years and 5 months
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Secondary outcome [1]
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Percentage of Participants with CR with Partial Hematological Recovery (CRh)
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Assessment method [1]
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Percentage of participants with CRh will be reported based on ELN 2017 response criteria assessment.
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Timepoint [1]
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Up to 3 years and 5 months
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Secondary outcome [2]
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Percentage of Participants with CR plus CRh
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Assessment method [2]
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Percentage of participants with CR plus CRh will be reported based on ELN 2017 response criteria assessment.
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Timepoint [2]
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Up to 3 years and 5 months
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Secondary outcome [3]
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Percentage of Participants with CR with Incomplete Recovery (CRi)
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Assessment method [3]
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Percentage of participants with CRi will be reported based on ELN 2017 response criteria assessment.
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Timepoint [3]
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Up to 3 years and 5 months
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Secondary outcome [4]
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Overall Response Rate (ORR)
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Assessment method [4]
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ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria assessment.
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Timepoint [4]
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Up to 3 years and 5 months
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Secondary outcome [5]
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Percentage of Participants with CR without MRD
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Assessment method [5]
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Percentage of participants with CR without minimal residual disease (MRD) will be reported and is defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3; determined by central lab).
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Timepoint [5]
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Up to 3 years and 5 months
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Secondary outcome [6]
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Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS)
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Assessment method [6]
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Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as less than (<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3).
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Timepoint [6]
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Up to 3 years and 5 months
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Secondary outcome [7]
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Time to Response
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Assessment method [7]
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Time to response, defined as time from randomization in Part 1 to achieving the first response of CR, CRh, or CRi.
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Timepoint [7]
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Up to 3 years and 5 months
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Secondary outcome [8]
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Duration of Response
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Assessment method [8]
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Duration of response is defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause.
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Timepoint [8]
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Up to 3 years and 5 months
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Secondary outcome [9]
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Red Blood Cell (RBC) or Platelets Transfusion Independence
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Assessment method [9]
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Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days.
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Timepoint [9]
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Up to 3 years and 5 months
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Secondary outcome [10]
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [10]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
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Timepoint [10]
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Up to 3 years and 5 months
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Secondary outcome [11]
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Minimum Serum Concentration (Cmin) of Cusatuzumab
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Assessment method [11]
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Cmin is the minimum observed serum concentration.
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Timepoint [11]
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Up to 2 years and 2 months
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Secondary outcome [12]
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Maximum Serum Concentration (Cmax) of Cusatuzumab
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Assessment method [12]
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Cmax is the maximum observed serum concentration.
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Timepoint [12]
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Up to 2 years and 2 months
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Secondary outcome [13]
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Number of Participants with Anti-cusatuzumab Antibodies
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Assessment method [13]
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Number of participants exhibiting anti-drug antibodies for cusatuzumab alone and in combination with azacitidine will be reported.
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Timepoint [13]
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Up to 3 years and 5 months
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Eligibility
Key inclusion criteria
- Acute myeloid leukemia (AML) according to World Health Organisation (WHO) 2016
criteria and fulfilling all of the following criteria that defines those who are "not
candidates for intensive chemotherapy":
1. greater than or equal to (>=)75 years of age or
2. less than (<) 75 years of age with at least one of the following comorbidities:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 2; Severe cardiac
comorbidity defined as congestive heart failure or ejection fraction less than or
equal to (<=) 50 percent (%); Severe pulmonary comorbidity defined as documented
pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) <=65%
of expected, or forced expiratory volume in 1 second (FEV1) <=65% of expected or
dyspnea at rest requiring oxygen; Moderate hepatic impairment defined according
to NCI organ dysfunction classification criteria (total bilirubin >=1.5 up to 3
times upper limit of normal [ULN]); Creatinine clearance <45 milliliter per
minute per 1.73 meter square (mL/ min/1.73 m^2); Comorbidity that, in the
Investigator's opinion, makes the participant unsuitable for intensive
chemotherapy and must be documented and approved by the Sponsor before
randomization
- De novo or secondary AML
- Previously untreated AML (except: emergency leukapheresis, hydroxyurea, and/or 1 dose
of cytarabine [example: 1-2 gram per meter square {g/m^2}] during the Screening Phase
to control hyperleukocytosis. These treatments must be discontinued >=24 hours prior
to start of study drug). Empiric all trans retinoic acid (ATRA) treatment for presumed
acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA
must be discontinued >=24 hours prior to the start of study drug
- Not eligible for an allogeneic hematopoietic stem cell transplantation
- ECOG Performance Status score of 0, 1 or 2
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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
- Acute promyelocytic leukemia
- Leukemic involvement or clinical symptoms of leukemic involvement of the central
nervous system
- Use of immune suppressive agents for the past 4 weeks before the first administration
of cusatuzumab on Cycle 1 Day 3. For regular use of systemic corticosteroids,
participants may only be included if free of systemic corticosteroids for a minimum of
5 days before the first administration of cusatuzumab. Treatment of adrenal
insufficiency with physiologic replacement doses of corticosteroids are allowed
- Prior treatment with a hypomethylating agent for treatment of AML or myelodysplastic
syndrome (MDS)
- Active malignancies (that is, progressing or requiring treatment in the last 24
months) other than the disease being treated under the study
- Any active systemic infection
- Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its
excipients (that is, mannitol, an excipient of azacitidine)
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
29/07/2019
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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
15/08/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Vincents Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment hospital [4]
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Royal Perth Hospital - Perth
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Campinas
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Country [2]
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Brazil
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State/province [2]
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Porto Alegre
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France
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State/province [3]
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Angers
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France
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State/province [4]
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Grenoble cedex 9
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Country [5]
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France
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State/province [5]
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Marseille Cedex 9
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Country [6]
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France
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State/province [6]
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Pessac
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Country [7]
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France
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State/province [7]
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Pierre - Bénite Cedex
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Country [8]
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France
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State/province [8]
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Toulouse Cedex 9
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Country [9]
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France
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State/province [9]
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Tours
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Country [10]
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Israel
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State/province [10]
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Haifa
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Israel
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State/province [11]
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Jerusalem
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Country [12]
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Israel
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State/province [12]
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Tel Aviv
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Country [13]
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Italy
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State/province [13]
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Bologna
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Country [14]
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Italy
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State/province [14]
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Brescia
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Italy
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Meldola
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Italy
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Milano
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Italy
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Napoli
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Italy
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State/province [18]
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Udine
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Country [19]
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Russian Federation
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State/province [19]
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Chelyabinsk
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Country [20]
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Russian Federation
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State/province [20]
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Ekaterinburg
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Russian Federation
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State/province [21]
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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Sochi
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Russian Federation
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State/province [27]
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St. Petersburg
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Country [28]
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Russian Federation
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State/province [28]
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Syktyvkar
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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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Palma
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Spain
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State/province [33]
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Pozuelo De Alarcon, Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Switzerland
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Aarau
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Switzerland
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Bern
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Country [38]
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Switzerland
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Geneve
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Country [39]
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Switzerland
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State/province [39]
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Zürich
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Country [40]
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Turkey
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State/province [40]
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Ankara
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Country [41]
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Turkey
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State/province [41]
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Atakum
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Country [42]
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Turkey
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State/province [42]
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Istanbul
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Country [43]
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Turkey
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State/province [43]
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Izmir
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Country [44]
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Turkey
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State/province [44]
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Trabzon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
OncoVerity, Inc.
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Address
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Country
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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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argenx
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Janssen Research & Development, LLC
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the efficacy of cusatuzumab in combination with
azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are
not eligible for intensive chemotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04023526
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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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Clayton Smith, MD
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Address
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OncoVerity, Inc.
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Country
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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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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04023526
Download to PDF