InO - A Retrospective Study of UK Patients With Leukaemia

NCT04456959 | Completed Results

• 1 other identifier: X9001222
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 4

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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Outcome Measures

Primary Outcomes (6)

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

  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.

  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

• Number of Participants According to Number of Lines of Salvage Therapy

  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.

  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

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

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

  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

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

  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.

  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

• Number of Participants Who Were Treated Previously With Blinatumomab

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

  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

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

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

  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 (33)

• Total Duration of Treatment With Inotuzumab Ozogamicin

  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

• Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles

  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

• Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles

  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

• Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption

  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

• Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses

  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

Study Arms (1)

Adult R/R ALL patients who have received InO

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.

Drug: Inotuzumab Ozogamicin

Interventions

Inotuzumab Ozogamicin DRUG

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.

Also known as: CMC-544

Adult R/R ALL patients who have received InO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

University Hospitals Bristol NHS Foundation Trust

Bristol, BS1 3NU, United Kingdom

Location

University College London Hospital NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

The Royal Marsden NHS Foundation Trust of Fulham Road

London, SW3 6JJ, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: July 7, 2020
• Study Start: January 6, 2020
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: September 28, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)