CompletedNot Applicable

Besponsa Post Marketing Surveillance Study

South Korea108 participantsStarted 2020-07-09

Plain-language summary

Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
. Patients to whom BESPONSA® is contraindicated as per the local labeling.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs)

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of Participants With Unexpected AEs and SAEs

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of Participants With Unexpected ADRs and SADRs

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of AEs According to Severity

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of AEs According to Action Taken

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Trial details

NCT IDNCT04307134

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-24

Results submitted2025-12-10

View on ClinicalTrials.gov More Hematologic Malignancy trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
. Patients to whom BESPONSA® is contraindicated as per the local labeling.

What they're measuring

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs)

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of Participants With Unexpected AEs and SAEs

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of Participants With Unexpected ADRs and SADRs

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of AEs According to Severity

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)

Number of AEs According to Action Taken

Timeframe: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)