Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who Discontinue ABL-Kinase Inhibitor Therapy

Overview
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Clinical trial to o evaluate the efficacy of AOP2014 in a randomized phase III, multicenter setting with post-study follow-up

Sponsor: Philipps-University Marburg

SEEK ID: https://ldh.kks-marburg.imise.uni-leipzig.de/projects/8

Public web page: Not specified

NFDI4Health PIs: No PIs for this Trial Project

Trial Project created: 27th Nov 2024

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : 29561

Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2b (Aop2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who Discontinue ABL-Kinase Inhibitor Therapy
Language of the title/name(*) : English

Acronym(s) of the Project

Acronym(*) : ENDURE-CML
Language of the acronym(*) : English

Description(s) of the Project

Description(*) : Clinical trial to o evaluate the efficacy of AOP2014 in a randomized phase III, multicenter setting with post-study follow-up
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : AOP2014

Keyword(*) : CML

Keyword(*) : Pegylated-Proline-Interferon Alpha 2b

Keyword(*) : ABL-Kinase Inhibitor Therapy

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : DKH 70112020
Name of the organisation/institution/group(*) : Philipps-University Marburg
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : info@kks.uni-marburg.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Philipps-University Marburg/KKS
Address : Karl-von-Frisch-Str. 4, 35043 Marburg
Web page : https://www.kks.uni-marburg.de
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT03117816

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Chronic Myeloid Leukemia (CML)
Terminology/classification(*) : ICD-10
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Neoplasms (II)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : No
Start date : 4 May 2017
End date : 26 January 2022
Mono- or multicentric? : Multicentric
Number of centers : 25
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 99
Unit of age(*) : Years
Eligible gender : Male, Female
Inclusion criteria : see protocol
Exclusion criteria : see protocol
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Pegylated-Proline-interferon alpha-2b
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Experimental
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Molecular relapse free survival
Description of the outcome measure : see protocol
Type of the outcome measure : Primary
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-3
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Not specified

Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who Discontinue ABL-Kinase Inhibitor Therapy

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