OncoMatch/Clinical Trials/NCT03934372
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
Is NCT03934372 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Ponatinib for acute myeloid leukemia.
Treatment: Ponatinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Primary Central Nervous System Lymphoma
Tumor Agnostic
Biomarker criteria
Required: BCR-ABL1 translocation
documentation of BCR-ABL translocation by conventional cytogenetics, metaphase FISH, or q-PCR
Required: ABL1 t315i
T315I kinase domain mutation
Required: RET mutation
mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity
Required: FLT3 mutation
mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity
Required: KIT mutation
mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity
Required: FGFR mutation
mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity
Required: PDGFR mutation
mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity
Required: TIE2 mutation
mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity
Required: VEGFR mutation
mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity
Demographics
Prior therapy
Must have received: BCR-ABL inhibitor — CML
resistant to or intolerant of at least 1 prior BCR-ABL-targeted TKI therapy
Must have received: BCR-ABL inhibitor — ALL
ALL who have progressed on or after all available or indicated therapies, which may have included 1 prior BCR-ABL-targeted TKI therapy
Must have received: induction chemotherapy — AML or other leukemias
AML or other leukemias who have progressed on or after at least 1 prior induction attempt (for France only)
Must have received: standard therapy — solid tumors (including CNS) or lymphomas
solid tumors (including tumors of the CNS) or lymphomas who have progressed despite standard therapy or for whom no effective standard therapy is available or indicated
Cannot have received: ponatinib
Ponatinib
Lab requirements
Cardiac function
SF < 27% by ECHO, OR EF < 50% by MUGA; abnormal QTcF on screening ECG, defined as QTcF of ≥ 450 ms; clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute MI within 6 months, NYHA Class III or IV CHF, arrhythmia requiring therapy unless approved by medical monitor/sponsor; uncontrolled hypertension
SF < 27% by ECHO, OR EF < 50% by MUGA; abnormal QTcF on screening ECG, defined as QTcF of ≥ 450 ms; clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute MI within 6 months, NYHA Class III or IV CHF, arrhythmia requiring therapy unless approved by medical monitor/sponsor; uncontrolled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT03934372 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ponatinib disqualifies patients from enrollment.
Does this trial require BCR-ABL1?
Yes, BCR-ABL1 translocation is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 t315i is a required biomarker for enrollment.
Does this trial require RET?
Yes, RET mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 17 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify