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Study of Revumenib, Cytarabine, and Fludarabine in Children with Relapsed or Refractory Acute Myeloid Leukemia

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What is this study about?

This study aims to evaluate the effectiveness of combining certain medications in children with Acute Myeloid Leukemia, which is a type of cancer that affects the blood and bone marrow. The research focuses on specific subtypes of this cancer characterized by certain genetic changes, known as KMT2A-r, NUP98-r, or NPM1-mut. These terms refer to specific mutations, which are permanent changes in the DNA that cause cells to grow abnormally. The study involves patients whose cancer has either returned after treatment or has not responded to initial therapy.

The treatment being investigated consists of revumenib used together with a chemotherapy regimen called FLA. This chemotherapy combination includes the drugs cytarabine and fludarabine, which are administered through an intravenous line, meaning they are delivered directly into a vein. Revumenib is taken orally as either a tablet or an oral solution. The goal is to determine how many patients experience a reduction in cancer cells after receiving up to two cycles of this combined treatment.

Who Can Join the Study?

  • Patients must be older than 30 days but no older than 18 years of age at the time they join the study.
  • Patients must have a performance status of 50% or higher on the Lansky or Karnofsky scale, which are tools used to measure how well a person can perform daily activities and their general health.
  • Patients may have leukemia in the central nervous system (the brain and spinal cord), categorized as CNS1, CNS2, or CNS3, as long as they show no physical signs or symptoms like facial nerve weakness or issues with the eyes or brain.
  • Patients must have completely recovered from the harmful side effects of all previous anti-cancer treatments.
  • Patients must have healthy kidneys (renal function), liver, and heart (cardiac function).
  • Patients must have a specific type of Acute Myeloid Leukemia that is either refractory (meaning the cancer did not respond to treatment) or relapsed (meaning the cancer came back after a period of improvement). This leukemia must involve specific genetic changes known as KMT2A-translocation, NUP98-rearrangement, or NPM1-mutation.
  • At least 21 days must have passed since the last anti-cancer treatment, such as chemotherapy, unless a specific pre-treatment is allowed by the study rules.
  • At least 84 days must have passed since an allogeneic transplant, which is a procedure where a patient receives healthy bone marrow or stem cells from a donor.
  • Patients must not show signs of graft versus host disease (GVHD), which is a condition where the donor’s cells attack the patient’s body, though mild skin issues being treated with creams are allowed.
  • At least 28 days must have passed since any cellular therapy, such as donor lymphocyte infusion (DLI), which involves giving the patient specific immune cells.
  • A parent or legal guardian must understand and provide written permission for the patient to participate.
  • Patients and their families must be able to follow the scheduled study visits and other rules of the trial.
  • Females who are able to become pregnant must have a negative pregnancy test within 10 days before starting treatment.
  • The white blood cell (WBC) count, which is a measure of certain immune cells in the blood, must be less than 25,000 per microliter before joining.

Who Cannot Join the Study?

  • Patients whose cancer is only found outside of the bone marrow (the spongy tissue inside bones where blood cells are made), which is called extramedullary disease.
  • Patients who are currently taking another experimental drug (a medicine being tested in a study).
  • Patients taking medications like cyclosporine or tacrolimus to prevent graft-versus-host disease (a condition where transplanted immune cells attack the body) or organ rejection after a transplant.
  • Patients with active graft-versus-host disease, except for very mild skin involvement.
  • Patients taking strong CYP3A4 inhibitors, which are drugs that interfere with how the liver processes certain medicines, unless they are specific types like itraconazole or ketoconazole.
  • Patients taking CYP3A4 inducers, which are drugs that speed up how the liver processes certain medicines, either during the study or within 14 days of starting the study drug.
  • Patients taking medicines that can change the heart rhythm, specifically those that affect the QT interval (the time it takes for the heart muscle to recharge between beats).
  • Patients with certain genetic syndromes that affect how the body functions, such as Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, or Shwachman syndrome.
  • Female patients who are pregnant or breastfeeding.
  • Female and male patients who are able to have children but are not using highly effective birth control.
  • Patients who have previously used revumenib or any other menin inhibitor (a type of medicine that targets a specific protein).
  • Patients with a baseline QTcF measurement greater than 450ms, which is a way to measure the heart’s electrical activity.
  • Patients with an allergy or hypersensitivity (an extreme immune reaction) to the study drug or any of its excipients (the inactive ingredients used to make the medicine).
  • Patients with an active, uncontrolled infection at the time they join the study.
  • Patients with Down Syndrome.
  • Patients whose leukemia developed as a result of previous treatments like cytotoxic chemotherapy (strong drugs used to kill cancer cells).
  • Patients with a specific genetic change called KMT2A partial duplication.
  • Patients with Mixed Lineage Leukemia (a type of blood cancer that has features of more than one type of white blood cell).
  • Patients with a history of congenital prolonged QT syndrome (a heart rhythm problem present from birth), congestive heart failure (a condition where the heart cannot pump blood well), or arrhythmia (an irregular heartbeat) in the last 6 months.
  • Patients with problems in the upper gastrointestinal tract (the throat, esophagus, or stomach) that could prevent the body from absorbing medicine taken by mouth.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
University Hospital Jena KöR Jena Germany

Other Sites

Site Name City Country Status
St. Anna Kinderspital GmbH Vienna Austria
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Azienda Ospedaliera di Padova Padua Italy
Universitaetsklinikum Erlangen AöR Erlangen Germany
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Roskilde University Roskilde Denmark
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Uctnbznesl Mrgugpp Cvklud Hpnsgihqukqlckitd Hamburg Germany
Ulybmpfldgdjsdyswxjig Aezhyfzg Augsburg Germany
Sfokjsp Kzdfqneci Ino Kijdtg Josaccsmh Ubjejoegladv Mhzywxrlnl Ilz Kwqbvi Mtpqpeuftvhusgp W Pzhnbyeq Poznan Poland
Fbleqtwp npxuxglnq Mysoc a Hestdsg Prague Czechia
Umpagzpfjnvysyxdskmis Mpnklyjh Aze Munster Germany
Ucdhctjdmoyxrl Cdmbcdt Kcrwqbwvo Gdansk Poland
Gncdzu Ubamjzuwuw Fnsvxfxdi Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
19.02.2026
Czechia Czechia
Not yet recruiting
19.02.2026
Denmark Denmark
Not yet recruiting
19.02.2026
Germany Germany
Not yet recruiting
19.02.2026
Italy Italy
Not yet recruiting
19.02.2026
Poland Poland
Not yet recruiting
19.02.2026
Sweden Sweden
Not yet recruiting
19.02.2026
The Netherlands The Netherlands
Not yet recruiting
19.02.2026

Trial locations

Investigated drugs:

Revumenib is an oral medication that is being studied to see how well it works in treating certain types of acute myeloid leukemia in children. It is given as either a tablet or a liquid solution.

Cytarabine and Fludarabine are chemotherapy drugs administered through an IV (intravenous) line. In this study, these medications are used together as part of a chemotherapy combination to treat the leukemia.

Acute Myeloid Leukemia – This is a type of cancer that affects the blood and bone marrow. It occurs when the bone marrow begins producing abnormal white blood cells called myeloblasts. These abnormal cells do not function correctly and multiply rapidly. As these cells build up, they crowd out healthy blood cells. The condition can progress quickly as the abnormal cells interfere with the production of red blood cells, normal white blood cells, and platelets.

Trial ID:
2025-521390-14-00
Protocol code:
STRIVE
Trial Phase:
Therapeutic exploratory (Phase II)

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