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RecruitingPhase 1Phase 2NCT03934372

Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in Pediatric Participants

Sponsor

Incyte Biosciences International Sàrl

Enrollment

70 participants

Start Date

Jan 29, 2020

Study Type

INTERVENTIONAL

Conditions

Solid TumorsAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaLymphomaLeukemiaAcute Lymphocytic LeukemiaAccelerated Phase Chronic Myeloid LeukemiaBlast Phase Chronic Myeloid LeukemiaChronic Phase Chronic Myeloid Leukemia

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to \< 18 years with advanced leukemias, lymphomas, and solid tumors.

Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety and effectiveness of ponatinib — a targeted cancer drug — in children and young adults with leukemias, lymphomas, or solid tumors that have not responded to or relapsed after standard treatments, including those with specific genetic mutations like BCR-ABL or T315I. **You may be eligible if...** - You have a confirmed diagnosis of CML (chronic myeloid leukemia in any phase), ALL, AML, another leukemia, lymphoma, or a solid tumor (including brain tumors) with no available standard therapy - For CML: your cancer is resistant to or intolerant of prior BCR-ABL targeted therapy, or you have the T315I mutation - You are a child or young adult meeting the age criteria and have adequate organ function **You may NOT be eligible if...** - You have not tried approved treatments first (depending on cancer type and study phase) - You have serious cardiovascular disease or other conditions making this drug unsafe - Your organ function does not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPonatinib

Ponatinib administered as a tablet or age-appropriate formulation for pediatric participants according to age-based cohort assignment.

Locations(23)

Ghent University Hospital

Ghent, Belgium

Hopital Robert Debre

Paris, France

Armand Trousseau Hospital

Paris, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Chu de Rennes - Hospital Sud

Rennes, France

Aou Policlinico S. Orsola-Malpighi

Bologna, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Italy

Ospedale Pediatrico G. Gaslini

Genova, Italy

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, Italy

University of Milano Bicocca

Monza, Italy

Aorn Santobono Pausilipon

Naples, Italy

Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

Pavia, Italy

Ospedale Pediatrico Bambino Gesu Irccs

Rome, Italy

A.O.U Citta Della Salute E Della Scienza Di Torino Presidio Ospedaliero Infantile Regina Margherita

Torino, Italy

Princess Maxima Center For Pediatric Oncology

Utrecht, Netherlands

Hospital General Universitario Vall D Hebron

Barcelona, Spain

Hospital Sant Joan de Deu de Manresa

Barcelona, Spain

Hospital Infantil Unversitario Nino Jesus

Madrid, Spain

Hospital Universitari I Politecnic La Fe

Valencia, Spain

Karolinska University Hospital Solna

Stockholm, Sweden

Royal Hospital For Sick Children Yorkhill Glasgow

Glasgow, United Kingdom

Alder Hey Childrens Nhs Foundation Trust

Liverpool, United Kingdom

The Royal Marsden Nhs Foundation Trust - Sutton

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03934372

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