Besponsa Post Marketing Surveillance Study

December 10, 2025 updated by: Pfizer

Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
  2. 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

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

  1. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.

  2. Patients to whom BESPONSA® is contraindicated as per the local labeling.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
R/R ALL
Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL)
Drug: Inotuzumab ozogamicin
R/R ALL who treated with Inotuzumab ozogamicin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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)
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to the end of study (maximum up to 311 days)
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
Time Frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Best Overall Response (BOR)
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR was defined as the best response recorded from the start of treatment until disease progression (PD) or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. Ineffectiveness was defined as BOR of refractory disease, PD, or relapsed disease. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. Refractory Disease: failure to achieve 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.
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
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of age (<65 years and >=65 years) in this outcome measure.
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
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of sex (female and male) in this outcome measure.
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
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of diagnosis (Philadelphia [+] B-cell ALL, Philadelphia [-] B-cell ALL and unknown) in this outcome measure.
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
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. Refractory Disease: failure to achieve 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. The number of participants with effective BOR were classified according to their baseline demographic characteristic 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) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Renal Disorder at Baseline
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of renal disorder (yes and no) in this outcome measure.
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 Hepatic Disorder at Baseline
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of hepatic disorder (yes and no) in this outcome measure.
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 Allergic History at Baseline
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of allergic history (yes and no) in this outcome measure.
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 VOD/SOS Status at Baseline
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. 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. The number of participants with effective BOR were classified according to their baseline demographic characteristic of VOD/SOS (yes and no) in this outcome measure.
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 Previous Systemic Therapy Status at Baseline
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of previous systemic therapy (yes, no and unknown) in this outcome measure.
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 Previous Hematopoietic Cell Transplant Status at Baseline
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC >1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of previous hematopoietic cell transplant (yes, no and unknown) in this outcome measure.
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 Usage of Concomitant Medication Throughout the Study
Time Frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to usage of concomitant medication (yes and no) in this outcome measure.
From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B1931027
  • NCT04307134 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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