RecruitingPhase IEN originalLeukemia

Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

The primary objective of the trial is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 0-21 lat, ważący co najmniej 5 kg (większość uczestników poniżej 18 lat)
  • •Ostra białaczka z mutacją KMT2A, NPM1 lub NUP98 w pierwszym lub kolejnym nawrocie
  • •Choroba oporna na standardowe leczenie, w tym przeszczep szpiku
  • •Potwierdzenie zmiany genetycznej przez centralną laboratorium
  • •Stan ogólny wystarczający do aktywności (co najmniej 60% funkcjonalności)
  • •Prawidłowa funkcja nerek - czyszczenie kreatyniny co najmniej 60 mL/min

Simplified criteria — AI translation

Trial details

Minimum age
0 Years
Maximum age
21 Years
Last updated (source)
October 9, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (20)

Children's Hospital Los Angeles

Los Angeles, United States

Children's Hospital Colorado

Aurora, United States

Children's Healthcare of Atlanta

Atlanta, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, United States

Dana-Farber Cancer Institute

Boston, United States

Memorial Sloan Kettering Cancer Center - New York

New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, United States

Children's Hospital of Philadelphia

Philadelphia, United States

St. Jude Children's Research Hospital

Memphis, United States

Texas Children's Hospital

Houston, United States

Seattle Children's Hospital

Seattle, United States

Sankt Anna-Kinderspital

Vienna, Austria

SickKids - The Hospital for Sick Children

Toronto, Canada

CHU de Nantes - Hôpital Femme-Enfant-Adolescent

Nantes, France

CHU de Reims - Hôpital Robert Debré

Paris, France

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Fondazione IRCCS San Gerardo dei Tintori (Ospedale San Gerardo)

Monza, Italy

Prinses Maxima Centrum Kinderoncologie

Utrecht, Netherlands

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/10/2026.

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