N/A
Completed N=32
A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment
Source: ClinicalTrials.gov NCT05597085 ↗Enrolled (actual)
32
Serious AEs
59.4%
Results posted
Feb 2025
Primary outcomePrimary: Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO — 19 Participants
Summary
The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment.
This retrospective Study enroll adult patients who:
* were CD22 positive (a molecule in the body that stops the over activity of the immune system)
* Received only InO for the treatment of B-cell ALL that occurred again after the last treatment
* were Philadelphia chromosome positive (which occurs because of changes in genes)
* failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division).
The patient data except their personal details are collected from a hospital based electronic medical record in India.
In this study the effectiveness and safety of InO will be studied after it was released to the market.
To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India:
* in whom the disease occurred again
* or those who never showed any improvement to earlier treatments
* now being treated with InO alone
Around 55 patients who have taken InO are likely to be enrolled in the study.
Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO |
19 | — |
| PRIMARY Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation |
6; 11; 2 | — |
| PRIMARY Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease |
10; 9 | — |
| SECONDARY Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi |
17; 1 | — |
| SECONDARY Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi |
5; 11; 2 | — |
| SECONDARY Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi |
10; 8 | — |
| SECONDARY Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years) |
2 | — |
| SECONDARY Median Number of Cycles of InO Treatment |
2 | — |
| SECONDARY Median Number of Cycles of InO Needed to Attain CR/CRi |
2 | — |
| SECONDARY Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies |
2.33; 2.00; 3.50 | — |
| SECONDARY Duration of Remission (DOR) |
6 | — |
| SECONDARY Number of Participants Categorized as Per InO Doses |
17; 12; 3 | — |
| SECONDARY Number of Participants With InO Dose Modifications |
17; 3 | — |
| SECONDARY Number of Participants Who Received Concomitant Medications |
— | — |
| SECONDARY Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT) |
11 | — |
| SECONDARY Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity |
66.7; 88.9; 33.3; 44.4 | — |
| SECONDARY Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies |
66.7; 50; 33.3; 50; 56; 25.0 | — |
| SECONDARY Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease |
71.43; 50; 42.86; 25; 57.14; 33.33 | — |
| SECONDARY Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years) |
50.0; 50.0 | — |
| SECONDARY Number of Participants Categorized According to Cause of Death |
4; 6; 2; 1; 1; 1 | — |
| SECONDARY Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT |
7; 6; 9.5 | — |
| SECONDARY Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD |
45.45; 10 | — |
| SECONDARY Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies |
20; 17; 50 | — |
| SECONDARY Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease |
18.75; 25.00 | — |
| SECONDARY Percentage of Participants With VOD in Elderly Participants (>65 Years) |
50.00 | — |
| SECONDARY Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation |
12 | — |
| SECONDARY Number of Participants With Hematological Toxicities Following InO Initiation |
28 | — |
| SECONDARY Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged ≥18 years old at the initiation of InO treatment
- Patients with relapsed/refractory B-cell ALL
- Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive
- Ph+ patients who have failed treatment with at least 1 TKI
Exclusion Criteria
- Patient not completing at least 1 cycle of InO therapy • Patient on InO in combination with chemotherapy
Data sourced from ClinicalTrials.gov (NCT05597085). 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.