Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Inotuzumab Ozogamicin

Immunoglobulins

Calicheamicins

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Immunotoxins

Immunoconjugates

Immunologic Factors

Relapsed/refractory ALL patients who are 18 years and over and initiated InO between 1st of June 2016 and date of data collection (to be confirmed). They will have accessed InO treatment via NHS commissioning, via the CUP, or via private purchase and will have at least 3 months follow up from the index date unless death occurs within that time.

Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.

Pfizer CT.gov Call Center

The purpose of this study is to describe the demographics and clinical characteristics, treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin in the real-world.

InO - A Retrospective Study of UK Patients With Leukaemia

A Retrospective Chart Review of UK Patients With Relapsed/Refractory Acute Lymphoblastic Leukaemia Treated With Inotuzumab Ozogamicin, a Real World Research Study

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.

In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.

In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.

In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.

In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.

In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.

In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.

In this outcome measure, total duration of InO treatment was reported.

In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.

In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.

In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.

In this outcome measure, number of participants according to prescribed starting InO dose, were reported.

In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.

In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.

In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.

CR was defined as documented in medical records or (if unavailable in the records) as less than (\<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to \[\>=\] 100\*10\^9 cells per liter \[/L\] and absolute neutrophil counts \[ANC\] \>=1\*10\^9 cells/L) and resolution of any extramedullary disease.

CRi was defined as documented in medical records or (if unavailable in the records) \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\* 10\^9 cells/L and ANC \<1\*10\^9 cells/L) and resolution of any extramedullary disease.

In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \>=100\*10\^9 cells/L and ANC \>=1\*10\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\*10\^9 cells/L and ANC \<1\*10\^9 cells/L) and resolution of any extramedullary disease.

CR was defined as documented in medical records or as \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \>=100\*10\^9 cells/L and ANC \>=1\*10\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\*10\^9 cells/L and ANC \<1\*10\^9 cells/L) and resolution of any extramedullary disease.

Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \>=100\*10\^9 cells/L and ANC \>=1\*10\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\*10\^9 cells/L and ANC \<1\*10\^9 cells/L) and resolution of any extramedullary disease.

Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \>=100\*10\^9 cells/L and ANC \>=1\*10\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\*10\^9 cells/L and ANC \<1\*10\^9 cells/L) and resolution of any extramedullary disease.

In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.

In this outcome measure, number of participants according to their cause of death were reported.

OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.

Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \>=100\*10\^9/L and ANC \>=1\*10\^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\*10\^9/L and ANC \<1\*10\^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of \>5\*10\^9 cells/L.

RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \>=100\*10\^9 cells /L and ANC \>=1\*10\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\*10\^9 cells/L and ANC \<1\*10\^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of \>5\*10\^9 cells/L.

NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.

In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.

CR was defined as documented in medical records or as \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \>=100\*10\^9 cells/L and ANC \>=1\*10\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \<100\*10\^9 cells/L and ANC \<1\*10\^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of \>5\*10\^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not \>50%.

In this outcome measure, number of participants who survived at completion of InO treatment were reported.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.

AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.

In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked

Pfizer

Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs were reported as per participants' medical records. There was no specific medical dictionary.

Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.

Inotuzumab Ozogamicin (InO)

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Here, time from ALL diagnosis to index date was reported. Index date: date of initiation of the first cycle of InO.

Time from ALL Diagnosis to Index Date

Not recorded

ECOG PS is used to measure quality of life of oncology participants with scores ranging from 0 to 5;where 0= fully active, able to carry on all pre-disease performance without restriction;1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work;2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>)50 percent (%) of waking hours;3= capable of only limited self-care, confined to bed or chair \>50% of waking hours;4= completely disabled, cannot carry on any self-care, totally confined to bed or chair;5= dead.

Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Here, number of participants are classified according to phase of ALL disease: complete remission (CR), 1st relapse, 2nd relapse, 3rd relapse, 4th or greater relapse. Remission = either the reduction or disappearance of the signs and symptoms of a disease. Relapse = return of a disease or the signs and symptoms of a disease after a period of improvement. Index date: date of initiation of the first cycle of InO.

Number of Participants According to Their Phase of Disease at Index Date

Here, number of participants are classified according to their history of liver disease prior to index date, as 1) No = no previous liver disease history, 2) Yes = previous liver disease history and 3) Not know. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO.

Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period

Here number analyzed signifies participants evaluable for this baseline characteristic.

Percentage of Positive Cell Blasts (CD22 expression test)

Here, number of participants were classified per ALL mutation type.

Number of Participants According to ALL Mutation Types

Blood Platelet Counts

Blood Absolute Neutrophil Counts

Blood Alanine Aminotransferase (ALT) Levels

Blood Aspartate Aminotransferase (AST) Levels

Blood Bilirubin Levels

Blood Albumin Levels

Blood Gamma Glutamyl Transferase (GGT)

Here number analyzed signifies participants evaluable for this characteristic.

Blood Alkaline Phosphatase (ALP) Levels

Here, number of participants are classified according to number of relapses of ALL relapse prior to index date. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO.

Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period

The full analysis set (FAS) comprised of medical records extracted for the purpose of the study from all eligible participants who were included in the study.

Pfizer ClinicalTrials.gov Call Center

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline

Number of Participants According to Number of Lines of Salvage Therapy

Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had at least 1 line of prior HSCT recorded.

Number of Participants According to Type of Conditioning Regimen for Each HSCT

Number of Participants Who Were Treated Previously With Blinatumomab

Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies

Total Duration of Treatment With Inotuzumab Ozogamicin

Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles

Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles

Cycle 1: Cycle was not Interrupted

Cycle1: Interrupted Due to Death

Cycle 1:Interrupted Due to Liver toxicity Treatment Related Adverse Events (TRAEs)

Cycle 1: Interrupted Due to Neutropenia and Severe Constipation

Cycle 1: Interrupted Due to SARS-CoV 2 infection

Cycle 2: Cycle was not Interrupted

Cycle 2: Interrupted Due to High Fever, Rigors, Vomiting, Hypotension

Cycle 2: Interrupted Due to Liver Toxicity TRAE(s)

Cycle 2: Interrupted Due to Nausea, Poor oral intake, Neutropenic Sepsis

Cycle 3: Cycle was not Interrupted

Cycle 3: Interrupted Due to Infection in Peripherally Inserted Central Catheter

Cycle 3: Interrupted Due to Transferred to Another Hospital

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies number of participants evaluable for specified rows.

Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption

Cycle 1: 0.8 milligram per meter square (mg/m^2)

Cycle 1: 1.8 mg/m^2

Cycle 2: 1.0 mg/m2

Cycle 2: 1.2 mg/m^2

Cycle 2: 1.5 mg/m^2

Cycle 2: 1.8 mg/m^2

Cycle 3: 1.5 mg/m^2

Cycle 3: 1.8 mg/m^2

Cycle 4: 0.5 mg/m^2

Cycle 4: 1.5 mg/m^2

Cycle 5: 1.5 mg/m^2

Cycle 6: 1.5 mg/m^2

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for specific rows.

Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses

Cycle 1

Cycle 2

Cycle 3

Cycle 4

Cycle 5

Cycle 6

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, number analyzed signifies participants evaluable for specific rows.

Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose

Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and were treated with concomitant azole antifungal therapy.

Duration of Concomitant Azole Antifungal Therapy

Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment

Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment

Number of Participants With CR/CRi by the End of InO Treatment

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi.

Median Time to CR/CRi

Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with negative MRD.

Number of Participants Who Achieved Negative MRD Classified Per InO Cycles

3 months

6 months

12 months

Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Number of Participants Classified According to Their Cause of Death

Overall Survival (OS)

Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation

Relapse-free Survival (RFS)

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall number of Participants" signifies evaluable for this outcome measure.

Time to Non-relapse Mortality (NRM)

Chemotherapy

HSCT

CAR-T cell therapy

Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment

HSCT: CR

HSCT: CRi

HSCT: Not Known

CAR-T cell therapy: CR

CAR-T cell therapy: CRi

CAR-T cell therapy: PD

CAR-T cell therapy: Not Known

Blinatumomab: CR

Blinatumomab: Not Recorded

Blinatumomab: PD

Blinatumomab: SD

Other Chemotherapy: CR

Other Chemotherapy: CRi

Other Chemotherapy: Missing

Other Chemotherapy: Not Recorded

Other Chemotherapy: PD

Other Chemotherapy: SD

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for each category.

Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments

Number of Participants Who Survived Post InO Blinatumomab Treatment

Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment

FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS.

Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)

Spots Global Cancer Trial Database for InO - A Retrospective Study of UK Patients With Leukaemia

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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