Chronic Myeloid LeukemiaNCT03709017
Iclusig PMS in CML or Ph+ALL Patients
An observational study of Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
- What is being tested?
- Ponatinib
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2018to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are prescribed Iclusig® tablets and provide written informed consent will be enrolled. The number of patients to be enrolled by each investigator will vary.
Who may be able to join
- Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"
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.
- Being tested
- Ponatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PonatinibDrug
Also called Iclusig
Iclusig 45mg, 15mg
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Measured: until 14 days after last administration
Secondary outcomes (6)
The number of subjects who satisfy CHR
Measured: at 3 months and 6 months from administration
The percentage of subjects who satisfy CHR
Measured: at 3 months and 6 months from administration
The number of subjects who satisfy MCyR
Measured: at 3 months and 6 months from administration
The percentage of subjects who satisfy MCyR
Measured: at 3 months and 6 months from administration
The number of subjects who satisfy MMR
Measured: at 3 months and 6 months from administration
The percentage of subjects who satisfy MMR
Measured: at 3 months and 6 months from administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start7 Aug 2018
- Primary completion29 Nov 2022
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709017
- Sponsor's protocol ID
- 297-402-00002
- Status last verified
- Dec 2022
- First submitted
- 11 Oct 2018
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee 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.
PubMed 42174310
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"
- ClinicalTrials.gov ID
- NCT03709017
- Acronym / sponsor ID
- 297-402-00002
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are prescribed Iclusig® tablets and provide written informed consent will be enrolled. The number of patients to be enrolled by each investigator will vary.
Key inclusion criteria (1 listed)
- Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PonatinibAlso: IclusigIclusig 45mg, 15mg | Drug | – |
Primary outcome
The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Time frame: until 14 days after last administration
6 secondary outcomes
The number of subjects who satisfy CHR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy CHR
Time frame: at 3 months and 6 months from administration
The number of subjects who satisfy MCyR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy MCyR
Time frame: at 3 months and 6 months from administration
The number of subjects who satisfy MMR
Time frame: at 3 months and 6 months from administration
The percentage of subjects who satisfy MMR
Time frame: at 3 months and 6 months from administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 42174310Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR (time frame: until 14 days after last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.