A study evaluating the safety and efficacy of ponatinib for the treatment of recurrent or refractory leukemias or solid tumors in children

You may be able to join if

• Participants are eligible to be included in the study only if all of the following criteria apply: 1. Histologically or cytologically confirmed diagnosis of the following malignancies: a. Phase 1: CP-CML, BP-CML, AP-CML ALL. AML. Other leukemias. Lymphoma. Any other tumors, including tumors of the CNS, for which standard therapy is not available or is not indicated. b. Phase 2, Group A with CP-CML: CP-CML at the time of study entry and must be resistant to or intolerant of at least 1 prior BCR-ABL–targeted TKI therapy or have the T315I kinase domain mutation or be in ""warning"" response status. Warning response status must a) be confirmed by at least 2 assessments performed at least 1 month apart and b) justify the change of treatment by comorbidities and tolerability. Must have 1 bone marrow aspirate with documentation of BCR-ABL translocation by conventional cytogenetics, metaphase FISH, or q-PCR performed within 42 days before the first dose of ponatinib. c. Phase 2, Group B with other leukemias or solid tumors: ALL. AML. Other leukemias. Lymphoma. Any other tumors, including tumors of the CNS, with mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity (eg, EPH receptors and SRC families of kinases) as assessed on fresh or archived tumor tissue. d. Participants with solid tumors or with lymphoma must have measurable disease by CT or MRI based on RECIST v1.1 or the Lugano lymphoma guidelines as determined by site radiology. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. "
• 2.Prior therapies as follows: a. Phase 1: Participants with CML who are resistant to or intolerant of to at least 1 prior BCR-ABL–targeted TKI therapy. Participants with ALL who have progressed on or after all available or indicated therapies, which may have included 1 prior BCR-ABL–targeted TKI therapy. Participants with AML or other leukemias who have progressed on or after at least 1 prior induction attempt (for France only) or for whom no effective standard therapy is available or indicated (other countries). Participants with 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. b. Phase 2, Group A with CP-CML: Participants who are resistant to or intolerant of at least 1 prior BCR ABL–targeted TKI therapy (exception for participants with T315I mutation) or are in warning status. c. Phase 2, Group B with other leukemias or solid tumors: Participants with ALL who have progressed on or after all available or indicated therapies, which must have included 1 prior BCR-ABL–targeted TKI therapy. Participants with AML or other leukemias who have progressed on or after at least 1 prior induction attempt (for France only) or for whom no effective standard therapy is available or indicated (other countries). Participants with solid tumors (including tumors of the CNS) or lymphomas who progressed despite standard therapy or for whom no effective standard therapy is available or indicated. 3. Must have a parent or legal guardian able to comprehend and willing to sign a written ICF for the study and assent (when appropriate) according to local law, regulations, and institutional standards and to comply with all study visits and procedures. 4. Male and female participants ≥ 1 to < 18 years old, inclusive, at the time of signing the informed consent. 5. Karnofsky performance status ≥ 40% for participants ≥ 16 years old or Lansky Play Scale ≥ 40% for pediatric participants < 16 years old. 6. 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. 7. Willingness to avoid pregnancy or fathering children based on the criteria below. a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last dose of study treatment Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. b. Female participants of childbearing potential must have a negative serum pregnancy test at screening and before the first dose of study treatment on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 6 months after the last dose of study treatment (permanent discontinuation) Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. c. A female participant not considered to be of childbearing potential as defined in is eligible.