drugset / Trial / NCT06713837
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
Phase 3
Recruiting
339 enrolled
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Charite University, Berlin, Germany · collabCyprus Institute of Neurology and Genetics · collabCzech Lymphoma Study Group · collabEuropean LeukemiaNet · collabFundacion Para La Investigacion Hospital La Fe · collabFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · collabGerman Society for Pediatric Oncology and Hematology GPOH gGmbH · collabGruppo Italiano Malattie EMatologiche dell'Adulto · collabHannover Medical School · collabHospital Vall d'Hebron · collabLithuanian University of Health Sciences · collabOspedale Pediatrico Bambin Gesù · collabOstdeutsche Studiengruppe Haematologie Und Onkologie e.V. · collabTIMELEX · collabToscana Life Sciences Sviluppo s.r.l. · collabUniversity of Bologna · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
Timeline
- Start
- 2025-02-27
- Primary completion
- 2028-01
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | — | — |
| Comparator | Cladribine | Small molecule | 5 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | — | — |
| Comparator | Daunorubicin | Small molecule | — | — |
| Subject | Decitabine | Small molecule | — | — |
| Comparator | Etoposide | Small molecule | — | — |
| Comparator | Fludarabine | Small molecule | — | — |
| Subject | Gemtuzumab | Monoclonal antibody | — | — |
| Subject | Gilteritinib | Small molecule | — | — |
| Subject | Glasdegib | Small molecule | — | — |
| Comparator | Idarubicin | Small molecule | — | — |
| Subject | Ivosidenib | Small molecule | — | — |
| Comparator | Mitoxantrone | Small molecule | — | — |
| Subject | Venetoclax | Small molecule | — | — |