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

NCT ID: NCT06713837

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2028-01-31

Brief Summary

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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)

Detailed Description

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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)

Conditions

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Acute Myeloid Leukemia Relapse/Recurrence

Keywords

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Relapsed/Refractory Acute Myeloid Leukemia Low Intensity therapy Pragmatic Low intervention Clinical trial Randomized controlled trial Horizon Europe Mission Cancer Diagnosis and treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low intensity treatment

Low intensity treatments are based on the single agent use of innovative and target drugs or their combination with other target drugs and less-toxic agents in doublets or triplets.

Administration of low intensity therapies in combination with antibodies or target agents would be included in this cohort

Group Type EXPERIMENTAL

Low intensity therapies

Intervention Type DRUG

* Venetoclax+hypomethylating agent (decitabine, azacitidine)
* Venetoclax+low dose cytarabine
* Gilteritinib alone or in combination with low dose hypomethylating agent or low dose cytarabine
* 2CDA 5mg/sqm + low dose cytarabine
* Glasdegib+low dose cytarabine
* Ivosidenib alone or in combination with low dose hypomethylating agent or low dose cytarabine
* Single agent Gemtuzumab or Gemtuzumab in combination with alone or in combination with low dose hypomethylating agent or low dose cytarabine

High intensity treatment

Intensive treatment of leukemia is based on high dose of chemotherapy agents.

Administration of high-dose chemotherapy in combination with antibodies or target agents would be included in this cohort.

Group Type ACTIVE_COMPARATOR

High intensity therapies

Intervention Type DRUG

* High and intermediate dose Cytarabine
* Mitoxantrone - Etoposide - Cytarabine (MEC)
* fludarabine - cytarabine - idarubicin - G-CSF (FLAG-IDA)
* cladribine - high dose cytarabine (2CDA+HDAraC)
* mitoxantrone - intermediate dose cytarabine (MiDAC)
* fludarabine - amsacrine - cytarabine (FLAMSA)
* Mitoxantrone - Intermediate-dose Cytarabine (HAM)
* 3+7 (cytarabine and daunorubicine or idarubicine)

Interventions

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High intensity therapies

* High and intermediate dose Cytarabine
* Mitoxantrone - Etoposide - Cytarabine (MEC)
* fludarabine - cytarabine - idarubicin - G-CSF (FLAG-IDA)
* cladribine - high dose cytarabine (2CDA+HDAraC)
* mitoxantrone - intermediate dose cytarabine (MiDAC)
* fludarabine - amsacrine - cytarabine (FLAMSA)
* Mitoxantrone - Intermediate-dose Cytarabine (HAM)
* 3+7 (cytarabine and daunorubicine or idarubicine)

Intervention Type DRUG

Low intensity therapies

* Venetoclax+hypomethylating agent (decitabine, azacitidine)
* Venetoclax+low dose cytarabine
* Gilteritinib alone or in combination with low dose hypomethylating agent or low dose cytarabine
* 2CDA 5mg/sqm + low dose cytarabine
* Glasdegib+low dose cytarabine
* Ivosidenib alone or in combination with low dose hypomethylating agent or low dose cytarabine
* Single agent Gemtuzumab or Gemtuzumab in combination with alone or in combination with low dose hypomethylating agent or low dose cytarabine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

Cyprus Institute of Neurology and Genetics

OTHER

Sponsor Role collaborator

European Leukemia Net

UNKNOWN

Sponsor Role collaborator

Fundacion Para La Investigacion Hospital La Fe

OTHER

Sponsor Role collaborator

Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V.

UNKNOWN

Sponsor Role collaborator

Ospedale Pediatrico Bambin Gesù

OTHER

Sponsor Role collaborator

Czech Lymphoma Study Group

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

OTHER

Sponsor Role collaborator

University of Bologna

OTHER

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role collaborator

German Society for Pediatric Oncology and Hematology GPOH gGmbH

OTHER

Sponsor Role collaborator

Toscana Life Sciences Sviluppo s.r.l.

INDUSTRY

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role collaborator

TIMELEX

UNKNOWN

Sponsor Role collaborator

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Martinelli, MD, Prof

Role: STUDY_CHAIR

University of Bologna

Locations

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University Hospital Brno

Brno, , Czechia

Site Status RECRUITING

University Hospital Hradec Králové

Hradec Králové, , Czechia

Site Status NOT_YET_RECRUITING

University Hospital Olomouc

Olomouc, , Czechia

Site Status NOT_YET_RECRUITING

University Hospital in Ostrava

Ostrava, , Czechia

Site Status NOT_YET_RECRUITING

University Hospital in Pilsen

Pilsen, , Czechia

Site Status NOT_YET_RECRUITING

University Hospital Greifswald

Greifswald, , Germany

Site Status RECRUITING

University Hospital Halle

Halle, , Germany

Site Status RECRUITING

University Hospital of Rostock

Rostock, , Germany

Site Status RECRUITING

Policlinico Sant'Orsola

Bologna, BO, Italy

Site Status RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

Site Status NOT_YET_RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

Site Status NOT_YET_RECRUITING

Ospedali Riuniti Villa Sofia - Cervello

Palermo, PA, Italy

Site Status RECRUITING

Ospedale S.Spirito - ASL Pescara

Pescara, PE, Italy

Site Status NOT_YET_RECRUITING

Ospedale Santa Maria della Misericordia

Perugia, PG, Italy

Site Status RECRUITING

Ospedale Santa Maria delle Croci

Ravenna, RA, Italy

Site Status RECRUITING

Policlinico Tor Vergata

Roma, RM, Italy

Site Status RECRUITING

Policlinico Umberto I

Roma, RM, Italy

Site Status RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, TO, Italy

Site Status RECRUITING

A. O. Ordine Mauriziano

Torino, TO, Italy

Site Status RECRUITING

ASST degli Spedali Civili

Brescia, , Italy

Site Status RECRUITING

ASST Valle Olonda

Busto Arsizio, , Italy

Site Status RECRUITING

Istituto Oncologico Veneto IRCCS

Castelfranco Veneto, , Italy

Site Status RECRUITING

AOU Careggi

Florence, , Italy

Site Status RECRUITING

IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola, , Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status NOT_YET_RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

Napoli, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedale-Università Padova

Padua, , Italy

Site Status RECRUITING

Ospedale Infermi

Rimini, , Italy

Site Status RECRUITING

Ospedale San Bortolo

Vicenza, , Italy

Site Status RECRUITING

The Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, , Lithuania

Site Status RECRUITING

Hospital de Santa Maria

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Fundeni Clinical Institute

Bucharest, , Romania

Site Status RECRUITING

Instituto de Investigación Sanitaria La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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Czechia Germany Italy Lithuania Portugal Romania Spain

Central Contacts

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Oriana Nanni

Role: CONTACT

Phone: +39 0543739100

Email: [email protected]

Impact-aml coord Impact-aml coord

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jiri Mayer, Prof.

Role: primary

Pavel Žák, MD

Role: primary

Tomáš Szotkowski, MD

Role: primary

Zdeněk Kořístek,, MD

Role: primary

Pavel Jindra, MD

Role: primary

Adrian Schwarzer, MD

Role: primary

Judith Schaffrath, MD

Role: primary

Christian Junghanß, MD

Role: primary

Antonio Curti, MD

Role: primary

Matteo Emidio Dragani, MD

Role: primary

Fabio Guolo, MD

Role: primary

Antonino Mulè, MD

Role: primary

Prassede Salutari

Role: primary

Maria Paola Martelli, MD

Role: primary

Giovanni Marconi, MD

Role: primary

Adriano Venditti, MD

Role: primary

Saveria Capria, MD

Role: primary

Ernesta Audisio, MD

Role: primary

Daniela Cilloni, MD

Role: primary

Erika Borlenghi, MD

Role: primary

Elisabetta Todisco, MD

Role: primary

Alessandra Sperotto, MD

Role: primary

Francesco Mannelli, MD

Role: primary

Maria Benedetta Giannini, MD

Role: primary

Nicola Stefano Fracchiolla, MD

Role: primary

Valentina Mancini, MD

Role: primary

Mario Annunziata, MD

Role: primary

Federica Lessi, MD

Role: primary

Anna Maria Mianulli, MD

Role: primary

Davide Facchinelli, MD

Role: primary

Rolandas Gerbutavičius, MD

Role: primary

Joana Brioso Infante, MD

Role: primary

Daniel Coriu, MD

Role: primary

Pau Montesinos, MD

Role: primary

Other Identifiers

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2024-514517-35-00

Identifier Type: CTIS

Identifier Source: secondary_id

101104421

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRST204.07

Identifier Type: -

Identifier Source: org_study_id