CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 70 target
Drug / intervention
Ponatinibdrug
Likely dose
Not stated in record
Key inclusion· 15
  • ✓Histologically or cytologically confirmed diagnosis of eligible malignancies
  • ✓Phase 1: CP-CML, BP-CML, AP-CML, ALL, AML, other leukemias, lymphoma, or CNS tumors for which standard therapy not available or not indicated
  • ✓Phase 2 Group A: CP-CML resistant to, intolerant of, or in warning response to ≥1 prior BCR-ABL TKI, or T315I mutation
  • ✓Bone marrow aspirate with BCR-ABL translocation documented by cytogenetics, FISH, or q-PCR within 42 days
Key exclusion· 35
  • ✕Corticosteroids or hydroxyurea within 24 hours before first dose (BP-CML, ALL, AML)
  • ✕Vincristine within 7 days before first dose (BP-CML, ALL, AML)
  • ✕Other chemotherapy (excluding intrathecal) within 14 days before first dose (BP-CML, ALL, AML)
  • ✕Cytotoxic chemotherapy within 21 days (42 days for nitrosoureas/mitomycin C) before first dose (other participants)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03934372
NCT03934372Phase 2RecruitingHigh MomentumUpdated 2mo ago
Long Recruiting
CompareCT.gov

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

Incyte Biosciences International Sàrl·interventional·Posted May 1, 2019·Updated Apr 16, 2026

In Brief

A Phase 2 clinical trial evaluating Ponatinib for Acute Myeloid Leukemia and 8 related conditions. Currently recruiting, targeting 70 participants across 23 sites in 7 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia, Blast Phase Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Leukemia, Lymphoma, Solid Tumors
CountriesBelgium, France, Italy, Netherlands, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2Recruiting
202020212022202320242025202620272028
First PostedMay 1, 2019
Enrollment StartJan 29, 2020
Primary CompletionFeb 1, 2028
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 7.2 years agoPrimary completion in 1.6 years

Interventions

Ponatinibdrug

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