Clinical trial NCT04456959: InO - A Retrospective Study of UK Patients With Leukaemia
Official title: A Retrospective Chart Review of UK Patients With Relapsed/Refractory Acute Lymphoblastic Leukaemia Treated With Inotuzumab Ozogamicin, a Real World Research Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed/refractory Acute Lymphoblastic Leukemia who are aged 18 and over and initiated Inotuzumab Ozogamicin between 1st of June 2016 and date of data collection and received treatment via NHS commissioning, via the Compassionate Use Programme, or via private purchase.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsed/refractory ALL.
* Patients who initiated InO between 1st of June 2016 and date of data collection.
* Patients who accessed InO treatment via NHS commissioning, via the CUP, or via private purchase.
* Patient aged ≥18 years old at initiation of InO treatment

Exclusion Criteria:

* Patients initiated on treatment with InO at a different hospital than the ones selected in this study.
* Patients with \<3 months of follow-up since index date, unless death occurs \<3 months from index date.

Primary outcomes:
measure: Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline
timeFrame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Number of Lines of Salvage Therapy
timeFrame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)
timeFrame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Type of Conditioning Regimen for Each HSCT
timeFrame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Were Treated Previously With Blinatumomab
timeFrame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies
timeFrame: Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
Secondary outcomes:
measure: Total Duration of Treatment With Inotuzumab Ozogamicin
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Duration of Concomitant Azole Antifungal Therapy
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With CR/CRi by the End of InO Treatment
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Median Time to CR/CRi
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Achieved Negative MRD Classified Per InO Cycles
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation
timeFrame: At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Classified According to Their Cause of Death
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Overall Survival (OS)
timeFrame: InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation
timeFrame: At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Relapse-free Survival (RFS)
timeFrame: From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Time to Non-relapse Mortality (NRM)
timeFrame: Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment
timeFrame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments
timeFrame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Survived Post InO Blinatumomab Treatment
timeFrame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment
timeFrame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)
timeFrame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)
timeFrame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With Interrupted InO Treatment Due to VOD/SOS
timeFrame: Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With Moderate Severity VOD/SOS
timeFrame: Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study
measure: Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT
timeFrame: Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
measure: Number of Participants With Significant Risk Factors for VOD/SOS
timeFrame: From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust of Fulham Road
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: