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IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

NCT06713837 · Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
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Official title
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT
About this study
Thanks to recent advantages and results that demonstrate that low-intensity rescues may be quantitatively comparable to chemotherapy, novel personalized therapies are being slowly integrated into the treatment options of R/R AML. These new strategies, for the high interpatient variability, for the different cross-country reimbursement, for the school of thinking of treatment physicians, will wait decades to be proficiently compared with standard chemotherapy in the R/R setting, especially because most of the novel drugs are being pushed by the companies in the front-line (a setting that still has a large room for improvements). In IMPACT-AML RPCT, low-intensity therapies will be compared with high intensity chemotherapy rescue following a pragmatic, clinical-oriented approach. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
Eligibility criteria
Inclusion Criteria: * Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria * 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022 * Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician * Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice * No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to: i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization * Male or Female, aged\>18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<4 * A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. * Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: * Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment) * Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization * Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
Study design
Enrollment target: 339 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-27
Estimated completion: 2028-01
Last updated: 2026-04-08
Interventions
Drug: High intensity therapiesDrug: Low intensity therapies
Primary outcomes
  • To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy. (36 months)
Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · other
With: Hospital Vall d'Hebron, Cyprus Institute of Neurology and Genetics, European Leukemia Net, Fundacion Para La Investigacion Hospital La Fe, Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V., Ospedale Pediatrico Bambin Gesù, Czech Lymphoma Study Group, Charite University, Berlin, Germany, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León, University of Bologna, Hannover Medical School, German Society for Pediatric Oncology and Hematology GPOH gGmbH, Toscana Life Sciences Sviluppo s.r.l., Lithuanian University of Health Sciences, Gruppo Italiano Malattie EMatologiche dell'Adulto, TIMELEX
Contacts & investigators
ContactOriana Nanni · contact · cc.ubsc@irst.emr.it · +39 0543739100
ContactImpact-aml coord Impact-aml coord · contact · impact-aml@irst.emr.it
InvestigatorGiovanni Martinelli, MD, Prof · study_chair, University of Bologna
All locations (47)
University Hospital BrnoRecruiting
Brno, Czechia
University Hospital Hradec KrálovéNot Yet Recruiting
Hradec Králové, Czechia
University Hospital OlomoucNot Yet Recruiting
Olomouc, Czechia
University Hospital in OstravaNot Yet Recruiting
Ostrava, Czechia
University Hospital in PilsenNot Yet Recruiting
Pilsen, Czechia
Uniklinik RWTH AachenRecruiting
Aachen, Germany
University Hospital GreifswaldRecruiting
Greifswald, Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbHNot Yet Recruiting
Halle, Germany
University Hospital HalleRecruiting
Halle, Germany
University Hospital of RostockRecruiting
Rostock, Germany
Heinrich-Braun-Klinikum gGmbHNot Yet Recruiting
Zwickau, Germany
Policlinico Sant'OrsolaRecruiting
Bologna, BO, Italy
IRCCS Ospedale Policlinico San MartinoNot Yet Recruiting
Genova, GE, Italy
IRCCS Ospedale Policlinico San MartinoNot Yet Recruiting
Genova, GE, Italy
Ospedali Riuniti Villa Sofia - CervelloRecruiting
Palermo, PA, Italy
Ospedale S.Spirito - ASL PescaraNot Yet Recruiting
Pescara, PE, Italy
Ospedale Santa Maria della MisericordiaRecruiting
Perugia, PG, Italy
Ospedale Santa Maria delle CrociRecruiting
Ravenna, RA, Italy
Policlinico Tor VergataRecruiting
Roma, RM, Italy
Policlinico Umberto IRecruiting
Roma, RM, Italy
AOU Città della Salute e della Scienza di TorinoRecruiting
Torino, TO, Italy
A. O. Ordine MaurizianoRecruiting
Torino, TO, Italy
Azienda Ospedaliero Universitaria Delle MarcheNot Yet Recruiting
Ancona, Italy
ASST degli Spedali CiviliRecruiting
Brescia, Italy
ASST Valle OlondaRecruiting
Busto Arsizio, Italy
Istituto Oncologico Veneto IRCCSRecruiting
Castelfranco Veneto, Italy
AOU CareggiRecruiting
Florence, Italy
IRST Istituto Romagnolo per lo Studio dei Tumori Dino AmadoriRecruiting
Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Italy
ASST Grande Ospedale Metropolitano NiguardaNot Yet Recruiting
Milan, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNot Yet Recruiting
Naples, Italy
Azienda Ospedale-Università PadovaRecruiting
Padova, Italy
Fondazione IRCCS Policlinico San MatteoNot Yet Recruiting
Pavia, Italy
Azienda Unita Sanitaria Locale Di PiacenzaNot Yet Recruiting
Piacenza, Italy
Ospedale InfermiRecruiting
Rimini, Italy
Casa Sollievo Della SofferenzaNot Yet Recruiting
San Giovanni Rotondo, Italy
Azienda Ospedaliero-Universitaria SeneseNot Yet Recruiting
Siena, Italy
Ospedale San BortoloRecruiting
Vicenza, Italy
The Hospital of Lithuanian University of Health Sciences Kauno KlinikosRecruiting
Kaunas, Lithuania
Hospital de Santa MariaRecruiting
Lisbon, Portugal
Fundeni Clinical InstituteRecruiting
Bucharest, Romania
Hospital General Universitario De AlbaceteNot Yet Recruiting
Albacete, Spain
Hospital General Universitario Dr. BalmisNot Yet Recruiting
Alicante, Spain
Hospital Universitari Vall D HebronNot Yet Recruiting
Barcelona, Spain
Hospital Clinico Universitario De ValenciaNot Yet Recruiting
Valencia, Spain
Consorcio Hospital General Universitario De ValenciaNot Yet Recruiting
Valencia, Spain
Instituto de Investigación Sanitaria La FeRecruiting
Valencia, Spain