About this trial

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 criteria

Qualifiers

Karnofsky performance status ≥ 40% for participants ≥ 16 years old or Lansky Play Scale ≥ 40% for pediatric participants < 16 years old.

Participants must have recovered to < Grade 2 per the NCI CTCAE v5.0 or to baseline from any non-hematologic toxicities (except alopecia) due to previous therapy.

Willingness to avoid pregnancy or fathering children.

Immunosuppressive therapy (including post stem cell transplant regimens) within 14 days before the first dose of ponatinib.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Ponatinib

Treatment groups

70 Participants
are divided into 1 treatment group

Locations

23
Belgium
Ghent University Hospital09000, Ghent Belgium
France
Armand Trousseau Hospital75571, Paris France
Hopital Robert Debre75019, Paris France
Centre Hospitalier Universitaire de Poitiers86021, Poitiers France

Sponsors and collaborators

Incyte Biosciences International Sàrl

Lead sponsor