InO - A Retrospective Study of UK Patients With Leukaemia

Pfizer

Status: Completed

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatments: Drug: Inotuzumab Ozogamicin

Study type: Observational

Funder types: Industry

Identifiers

NCT04456959

X9001222

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

28 participants in 1 patient group

Adult R/R ALL patients who have received InO

Description:

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.

Treatment:

Drug: Inotuzumab Ozogamicin