Besponsa Post Marketing Surveillance Study

NCT04307134 | Completed Results FDA Drug

• 2 other identifiers: B1931027NCT04307134
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Malignancy

Keywords

Refractory and relapsed B-cell ALL

Outcome Measures

Primary Outcomes (22)

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

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event.

  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)

  An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was an important medical event.

  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

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. An AE was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all AEs were unexpected.

  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

  An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was important medical event. In this outcome measure, number of participants with unexpected ADRs and SADRs are reported. An ADR was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all ADRs were unexpected.

  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

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs' severity was graded using common terminology criteria for AEs (CTCAE) version 4.0; grade 1= mild AE; grade 2= moderate AE; grade 3= severe AE; grade 4= life-threatening AE and grade 5= death.

  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

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per action taken for AEs (withdrawn \[temporarily or permanently or delayed\]; dose reduced; dose increased; dose not changed; unknown, and not applicable) in this outcome measure. Not applicable per protocol referred to situations if participant died or if the treatment was completed prior to the reaction/event or if drug was not administered.

  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 SAEs' Category

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per SAEs category (resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect and is an important medical event) in this outcome measure. One SAE could have more than 1 outcome/characteristic and have been counted in more than one category.

  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 Their Outcomes

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per their outcomes (recovered, recovered with sequelae, recovering, not recovered, and unknown) in this outcome measure.

  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 Based on Causality of AEs to the Study Drug

  AE: any untoward medical occurrence in participant administered medicinal product. Number of AEs per causality of AE to study drug (certain, probable/likely, possible, unlikely, conditional/unclassified, and not-assessable/unclassifiable) were reported. Certain: couldn't be explained by other drugs, had clinically reasonable reaction on cessation of drug and pharmacological/phenomenological reaction to drug re-administration. Probable/likely: couldn't be explained by other drugs, had clinically reasonable reaction on drug cessation. Possible: could also be explained by other drugs, lacked information/unclear information on drug discontinuation. Unlikely: not likely to have causal relationship from drug administration, could also be explained by other drugs. Conditional/unclassified: needed more data to make appropriate assessment/additional of data being reviewed. Not-assessable: lacked sufficient information/conflicting information hampering accurate causality assessment.

  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 Based on Other Causality of AEs

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of AEs were classified as per other causality of AE to the study drug (disease under the study, other disease, concomitant treatment drug or non-drug, and others) in this outcome measure.

  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 AEs Classified According to Their Age at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of age (less than \[\<\] 65 years and more than or equal to \[\>=\] 65 years) in this outcome measure.

  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 AEs Classified According to Their Sex at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of sex (female and male) in this outcome measure.

  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 AEs Classified According to Their Diagnosis at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of diagnosis (Philadelphia \[+\] B-cell Acute Lymphoblastic Leukemia \[ALL\], Philadelphia \[-\] B-cell ALL, and unknown) in this outcome measure.

  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 AEs Classified According to Their Disease Status at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Refractory Disease: failure to achieve complete response (CR) at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, absolute neutrophil count (ANC) \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. Number of participants with AEs were classified according to their baseline demographic characteristics of disease status (refractory, first relapsed, second relapsed and third or more relapsed) in this outcome measure.

  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 AEs Classified According to Their Renal Disorder Status at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of renal disorder status (yes or no) in this outcome measure.

  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 AEs Classified According to Their Hepatic Disorder Status at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of hepatic disorder status (yes or no) in this outcome measure.

  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 AEs Classified According to Their Allergic History Status at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of allergic history (yes or no) in this outcome measure.

  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 AEs Classified According to Their Veno-occlusive Liver Disease/ Sinusoidal Obstruction Syndrome (VOD /SOS) Status at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. VOD also known as SOS is a potentially life-threatening condition in which the small veins in the liver are blocked. This obstruction impairs blood flow through the liver and can lead to liver damage and failure. Number of participants with AEs were classified according to their baseline demographic characteristics of VOD/SOS (yes or no) in this outcome measure.

  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 AEs Classified According to Their Previous Systemic Therapy Status at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous systemic therapy status (yes, no, and unknown) in this outcome measure.

  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 AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous hematopoietic cell transplant status (yes, no, and unknown) in this outcome measure.

  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 AEs Classified According to Usage of Concomitant Medication Throughout the Study

  An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to the use of concomitant medications (yes and no) in this outcome measure.

  From first dose of study intervention (Day 1) up to the end of study (maximum up to 311 days)

• Number of Elderly Participants With ADRs

  An ADR was any untoward medical occurrence attributed to a medicinal product in a participant who had received that product. In this outcome measure, number of elderly participants (\>=65 years) with ADRs at baseline were reported.

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

Secondary Outcomes (12)

• Number of Participants With Best Overall Response (BOR)

  From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

• Number of Participants With Effective BOR Classified According to Their Age at Baseline

  From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

• Number of Participants With Effective BOR Classified According to Sex at Baseline

  From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

• Number of Participants With Effective BOR Classified According to Their Diagnosis at Baseline

  From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

• Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline

  From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

Study Arms (1)

R/R ALL

Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL)

Drug: Inotuzumab ozogamicin

Interventions

Inotuzumab ozogamicin DRUG

R/R ALL who treated with Inotuzumab ozogamicin

R/R ALL

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).

You may qualify if:

• 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.

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hematologic Neoplasms; Burkitt Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 13, 2020
• Study Start: July 9, 2020
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)