Besponsa Post Marketing Surveillance Study

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: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Drug: Inotuzumab ozogamicin

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: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Pfizer

Participation Criteria

Eligibility Criteria

• 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.

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Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Best Overall Response (BOR)	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): December 24, 2024
• Study Completion (Actual): December 24, 2024

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Refractory and relapsed B-cell ALL
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Infections; Virus Diseases; Neoplasms by Histologic Type; Hematologic Diseases; DNA Virus Infections; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Epstein-Barr Virus Infections; Herpesviridae Infections; Tumor Virus Infections; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Burkitt Lymphoma; Amino Acids, Peptides, and Proteins; Proteins; Carbohydrates; Glycosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Aminoglycosides; Calicheamicins; Inotuzumab Ozogamicin
• Other Study ID 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