IMPACT-AML: A RANDOMIZED PRAGMATIC CLINICAL TRIAL FOR RELAPSE OR REFRACTORY ACUTE MYELOID LEUKEMIA

Phase 3

Recruiting

• Conditions: Acute myeloid leukemia

• Registration Number: 2024-514517-35-00
• Lead Sponsor: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-27
• Last Update Posted: 2025-06-23

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 361

Inclusion Criteria

Non-APL AML defined according WHO 2022 (or ICC 2022) criteria

1st or 2nd relapse or refractory according to ELN 2022

Patient is clinically candidate both to low intensity therapy and to 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

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 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

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first		Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
Proportion of patients experiencing adverse events		Proportion of patients experiencing adverse events
Overall survival, defined as time from randomization to the date of death from any cause		Overall survival, defined as time from randomization to the date of death from any cause
Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort		Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort
Change in Hematologic Malignancy–Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment.		Change in Hematologic Malignancy–Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment.

Trial Locations

Locations (32)

Rostock University Medical Center; 🇩🇪 Rostock, Germany

Universitaetsklinikum Halle (Saale) AöR; 🇩🇪 Halle Saale, Germany

Universitaetsmedizin Greifswald KöR; 🇩🇪 Greifswald, Germany

Fakultni Nemocnice Ostrava; 🇨🇿 Ostrava, Czechia

Fakultni Nemocnice Brno; 🇨🇿 Brno, Czechia

University Hospital Olomouc; 🇨🇿 Olomouc, Czechia

Fakultni Nemocnice Plzen; 🇨🇿 Plzen 23, Czechia

Fakultni Nemocnice Hradec Kralove; 🇨🇿 Novy Hradec Kralove, Czechia

Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos; 🇱🇹 Kaunas, Lithuania

Hospital Universitario Y Politecnico La Fe; 🇪🇸 Valencia, Spain

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Rostock University Medical Center

🇩🇪Rostock, Germany

Christian Junghanß

Site contact

+493814947549

christian.junghanss@med.uni-rostock.de