WORKPLAN
The structure of the IMPACT-AML is designed to be simple, flexible and efficient. It is designed to ensure effective processing of knowledge and information and high-quality execution of project tasks.
Work Packages
| WP | Brief Description | Objective | Main partners |
|---|---|---|---|
| WP1 | Coordination | Set up an effective coordination and management framework to ensure the progress of the project toward its planned objectives and respect contractual commitments. |
IRST, all |
| WP2 | Development of the STREAM master framework | Design and develop the STREAM master framework, a platform that will be used for the collection of data of R/R AML and support the initiation of new pragmatic clinical trials across Europe. |
CING, Clinical Partners |
| WP3 | Creation of standard operating procedures for biobanking and MRD | Create SOP for tissue biobanking and MRD in patients with R/R AML in order to constitute a common decentralized archive of available tissues fostering translational research in AML and a common system for evaluation of response at an unprecedented level. |
CHR, MLU, ELN, Clinical Partners |
| WP4 | Preparation of study documentation, eCRF, consent, legal, submission | Prepare the documentation package and perform central European submission of the RPCT protocol for the approval by the Ethic Committee. |
IRST, TLX, Cooperative Study Groups ALAN |
| WP5 | Conduct RPCT | Enroll 339 R/R AML patients across Europe using STREAM as an inclusion platform, randomize patients in RPCT, treat patients according to the experimental arm, and collect data. |
IRST, Cooperative Study Groups |
| WP6 | Conduct cohort portfolio studies in pediatric setting | Describe clinical and biological outcomes of R/R AML in children. | OPBG, BFM |
| WP7 | Conduct cohort studies for orphan settings | Provide descriptive statistics for rare and neglected populations not included in the RPCT. |
OSHO, Clinical Partners |
| WP8 | Ensure data quality and agile monitoring strategies | Collect data and ensure data quality for patients enrolled in RPCT | IRST, Cooperative Study Groups |
| WP9 | HTA & QOL | Co-designed development of endpoints related to psychosocial factors in the clinical trial. |
UNIBO, ALAN, Clinical Partners |
| WP10 | Data analysis | Develop and update the Data Management Plan. Analyze data retrieved in RPCT reporting results for trial endpoint. |
IRST, CING, all |
| WP11 | Dissemination and exploitation of results | Disseminate and exploit IMPACT-AML results in a patient-centered fashion, to maximize the benefit derived from the project at multiple levels. Promote the scientific collaboration in R/R AML across Europe and beyond. |
TLS, ELN, IRST, VHIR, all |