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

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)

Conditions

• Acute Myeloid Leukemia
• Relapse/Recurrence

Interventions

DRUG

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)

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

Sponsors & Collaborators

• Hospital Vall d'Hebron

  collaborator OTHER

• Cyprus Institute of Neurology and Genetics

  collaborator OTHER

• European Leukemia Net

  collaborator UNKNOWN

• Fundacion Para La Investigacion Hospital La Fe

  collaborator OTHER

• Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V.

  collaborator UNKNOWN

• Ospedale Pediatrico Bambin Gesù

  collaborator OTHER

• Czech Lymphoma Study Group

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

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

  collaborator OTHER

• University of Bologna

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• German Society for Pediatric Oncology and Hematology GPOH gGmbH

  collaborator OTHER

• Toscana Life Sciences Sviluppo s.r.l.

  collaborator INDUSTRY

• Lithuanian University of Health Sciences

  collaborator OTHER

• Gruppo Italiano Malattie EMatologiche dell'Adulto

  collaborator OTHER

• TIMELEX

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• Giovanni Martinelli, MD, Prof · University of Bologna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-27

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• Czechia
• Germany
• Italy
• Lithuania
• Portugal
• Romania
• Spain

Study Locations