N/A
Completed N=28
InO - A Retrospective Study of UK Patients With Leukaemia
Source: ClinicalTrials.gov NCT04456959 ↗Enrolled (actual)
28
Serious AEs
7.1%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline — 27; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline |
27; 1 | — |
| PRIMARY Number of Participants According to Number of Lines of Salvage Therapy |
6; 1; 21 | — |
| PRIMARY Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) |
10; 15; 3 | — |
| PRIMARY Number of Participants According to Type of Conditioning Regimen for Each HSCT |
7; 1; 2 | — |
| PRIMARY Number of Participants Who Were Treated Previously With Blinatumomab |
4; 24 | — |
| PRIMARY Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies |
0; 18; 10 | — |
| SECONDARY Total Duration of Treatment With Inotuzumab Ozogamicin |
71.4 | — |
| SECONDARY Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles |
6; 13; 5; 2; 0; 2 | — |
| SECONDARY Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles |
20; 7; 1 | — |
| SECONDARY Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption |
24; 1; 1; 1; 1; 19 | — |
| SECONDARY Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses |
1; 27; 1; 1; 9; 11 | — |
| SECONDARY Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose |
26; 2; 20; 2; 7; 2 | — |
| SECONDARY Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy |
26; 2 | — |
| SECONDARY Duration of Concomitant Azole Antifungal Therapy |
20 | — |
| SECONDARY Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment |
15 | — |
| SECONDARY Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment |
5 | — |
| SECONDARY Number of Participants With CR/CRi by the End of InO Treatment |
20 | — |
| SECONDARY Median Time to CR/CRi |
1.7 | — |
| SECONDARY Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi |
14 | — |
| SECONDARY Number of Participants Who Achieved Negative MRD Classified Per InO Cycles |
1; 7; 6 | — |
| SECONDARY Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation |
25; 19; 13 | — |
| SECONDARY Number of Participants Classified According to Their Cause of Death |
15; 1; 1; 1; 1 | — |
| SECONDARY Overall Survival (OS) |
11.7 | — |
| SECONDARY Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation |
82.1; 60.7; 39.3 | — |
| SECONDARY Relapse-free Survival (RFS) |
8.86 | — |
| SECONDARY Time to Non-relapse Mortality (NRM) |
12.69 | — |
| SECONDARY Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment |
16; 9; 8 | — |
| SECONDARY Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments |
5; 3; 1; 5; 1; 1 | — |
| SECONDARY Number of Participants Who Survived Post InO Blinatumomab Treatment |
8 | — |
| SECONDARY Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment |
2; 26 | — |
| SECONDARY Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) |
1; 1 | — |
| SECONDARY Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) |
1 | — |
| SECONDARY Number of Participants With Interrupted InO Treatment Due to VOD/SOS |
2 | — |
| SECONDARY Number of Participants With Moderate Severity VOD/SOS |
2 | — |
| SECONDARY Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation |
1; 1 | — |
| SECONDARY Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation |
1; 1 | — |
| SECONDARY Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation |
1 | — |
| SECONDARY Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT |
— | — |
| SECONDARY Number of Participants With Significant Risk Factors for VOD/SOS |
1; 7; 0; 1; 1; 8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04456959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.