Iclusig 45 mg film-coated tablets

DRUG3 trials

Sponsors

Incyte Biosciences International S.a.r.l., Takeda Development Center Americas Inc., Goethe University Frankfurt

Conditions

Acute lymphoblastic leukemia (ALL)Chronic Phase Chronic Myeloid LeukemiaLymphomasPh/BCR::ABL1 positive (Ph+)Recurrent or Refractory Leukemiasand Solid Tumorsde novo

Phase 1

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

RecruitingCTIS2023-509699-41-00

Incyte Biosciences International S.a.r.l.and Solid Tumors, Lymphomas, Recurrent or Refractory Leukemias

Start: 2019-11-22Target: 57Updated: 2025-11-04

Phase 2

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

CompletedCTIS2024-514516-27-00

Takeda Development Center Americas Inc.Chronic Phase Chronic Myeloid Leukemia

Start: 2015-12-01End: 2025-04-23Target: 2Updated: 2025-02-25

A multicentre, randomized trial in adults with de novo Philadelphia-Chromosome positive acute lymphoblastic leukemia to assess the efficacy of ponatinib versus imatinib in combination with low-intensity chemotherapy, to compare end of therapy with indication for SCT versus TKI, blinatumomab and chemotherapy in optimal responders and to evaluate blinatumomab in suboptimal responders (GMALL-EVOLVE)

RecruitingCTIS2024-517966-40-00

Goethe University FrankfurtAcute lymphoblastic leukemia (ALL), de novo, Ph/BCR::ABL1 positive (Ph+)

Start: 2023-07-13Target: 208Updated: 2026-01-08