Clinical trial · Observational
A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment
A Retrospective Analysis of Inotuzumab Ozogamicin (InO) Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)
- 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 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.
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 |
|---|---|---|---|
| Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inotuzumab Ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Adult relapsed or refractory B Cell ALL
- description
- Adult patients whose B Cell ALL has occurred again after the last treatment or patients who never responded to prior treatment
- interventionNames
- Drug: Inotuzumab Ozogamicin
Primary outcomes (3)
- measure
- Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO
- timeFrame
- From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
- description
- CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available