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Clinical Trials in Germany / NCT06713837
Recruiting Phase 3

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

NCT06713837 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-02-27
Last updated
2026-08-14

Condition(s) studied

Acute Myeloid LeukemiaRelapse/Recurrence

Investigational drug(s) / intervention(s)

High intensity therapiesLow intensity therapies

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)

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

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
University Hospital Brno Brno Czechia Recruiting
University Hospital Hradec Králové Hradec Králové Czechia Not Yet Recruiting
University Hospital Olomouc Olomouc Czechia Not Yet Recruiting
University Hospital in Ostrava Ostrava Czechia Not Yet Recruiting
University Hospital in Pilsen Pilsen Czechia Recruiting
Uniklinik RWTH Aachen Aachen Germany Recruiting
University Hospital Greifswald Greifswald Germany Recruiting
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH Halle Germany Recruiting
University Hospital Halle Halle Germany Recruiting
University Hospital of Rostock Rostock Germany Recruiting
Heinrich-Braun-Klinikum gGmbH Zwickau Germany Recruiting
Policlinico Sant'Orsola Bologna BO Recruiting
IRCCS Ospedale Policlinico San Martino Genova GE Not Yet Recruiting
IRCCS Ospedale Policlinico San Martino Genova GE Recruiting
Ospedali Riuniti Villa Sofia - Cervello Palermo PA Recruiting
Ospedale S.Spirito - ASL Pescara Pescara PE Not Yet Recruiting
Ospedale Santa Maria della Misericordia Perugia PG Recruiting
Ospedale Santa Maria delle Croci Ravenna RA Recruiting
Policlinico Tor Vergata Roma RM Recruiting
Policlinico Umberto I Roma RM Recruiting
AOU Città della Salute e della Scienza di Torino Torino TO Recruiting
A. O. Ordine Mauriziano Torino TO Recruiting
Azienda Ospedaliero Universitaria Delle Marche Ancona Italy Recruiting
ASST degli Spedali Civili Brescia Italy Recruiting
ASST Valle Olonda Busto Arsizio Italy Recruiting
Istituto Oncologico Veneto IRCCS Castelfranco Veneto Italy Recruiting
AOU Careggi Florence Italy Recruiting
IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola Italy Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Recruiting
ASST Grande Ospedale Metropolitano Niguarda Milan Italy Not Yet Recruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Naples Italy Not Yet Recruiting
Azienda Ospedale-Università Padova Padova Italy Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia Italy Not Yet Recruiting
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy Recruiting
Ospedale Infermi Rimini Italy Recruiting
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy Recruiting
Azienda Ospedaliero-Universitaria Senese Siena Italy Recruiting
Ospedale San Bortolo Vicenza Italy Recruiting
The Hospital of Lithuanian University of Health Sciences Kauno Klinikos Kaunas Lithuania Recruiting
Hospital de Santa Maria Lisbon Portugal Recruiting

+ 7 more sites — see the full list on the official registry below.

More Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06713837 on ClinicalTrials.gov ↗ ← All trials in Germany