Clinical trial · Observational
Iclusig PMS in CML or Ph+ALL Patients
Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"
NCT03709017CI-TRIAL-00062554unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ponatinib | Drug | Ponatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
- timeFrame
- until 14 days after last administration
Secondary outcomes (6)
- measure
- The number of subjects who satisfy CHR
- timeFrame
- at 3 months and 6 months from administration
- measure
- The percentage of subjects who satisfy CHR
- timeFrame
- at 3 months and 6 months from administration
- measure
- The number of subjects who satisfy MCyR
- timeFrame
- at 3 months and 6 months from administration
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment Exclusion Criteria: * Patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug * Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
References
Publications (1)
- DERIVEDLee S, Kim HJ, Cheong JW, Shin HJ, Kong JH, Sohn SK, Yoon SS, Zang DY, Jung CW, Kim JA, Lee SE, Lee WS, Choi Y, Kim I, Han JJ, Kim MK, Chong SY, Kim DJ, Jo DY, Kim H, Kwak JY, Lee JH, Uhm J, Lee S, Lee MY, Kim DW. Real-world outcomes of ponatinib in heavily pretreated patients with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Ann Hematol. 2026 May 22;105(7):315. doi: 10.1007/s00277-026-07053-6. PMID 42174310