Clinical trial · Observational
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
NCT04456959CI-TRIAL-00061086InOcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inotuzumab Ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Inotuzumab Ozogamicin
Primary outcomes (6)
- 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
- description
- 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.
- measure
- Number of Participants According to Number of Lines of Salvage Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.