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

Recruiting Phase 3 Interventional Study
Acute Myeloid Leukemia Relapse/Recurrence
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
339 (estimated)
Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Other
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About This Trial

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)

Trial Locations
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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 candid…
Contacts

Oriana Nanni

+39 0543739100

cc.ubsc@irst.emr.it

CONTACT

Impact-aml coord Impact-aml coord

impact-aml@irst.emr.it

CONTACT