Phase 4
Completed N=44
A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT05687032 ↗Enrolled (actual)
44
Serious AEs
45.5%
Results posted
Aug 2025
Primary outcomePrimary: Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria — 81.8; 47.7; 34.1 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria |
81.8; 47.7; 34.1 | — |
| SECONDARY Duration of Remission (DoR) |
— | — |
| SECONDARY Percentage of Participants With Minimal Residual Disease (MRD) Negativity Among Who Achieved CR/CRi |
69.4 | — |
| SECONDARY Progression-free Survival (PFS) |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT) |
— | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5 |
— | — |
| SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) Based on NCI CTCAE Version 5 |
— | — |
| SECONDARY Number of Participants With TEAEs - Treatment Related Based on NCI CTCAE Version 5 |
— | — |
| SECONDARY Number of Participants With AEs According to Severity Based on NCI CTCAE Version 5 |
— | — |
| SECONDARY Number of Participants With Hematology Laboratory Parameters of Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline |
— | — |
| SECONDARY Number of Participants With Hematology Chemistry Parameters of Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline |
— | — |
| SECONDARY Number of Participants With Veno-occlusive Disease (VOD) |
— | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of InO on Day 1 of Cycle 1 and Cycle 4 |
273.3; 342.6 | — |
| SECONDARY Pre-dose Concentration (Ctrough) of InO on Day 1 of Cycle 4 |
85.33 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) to InO |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participants, age 18 years or older at screening.
- Relapsed or refractory CD22-positive ALL.
- Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
- Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy.
- Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment.
- ECOG performance status 0-2.
- Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.
Exclusion Criteria
- Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
- Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
Data sourced from ClinicalTrials.gov (NCT05687032). 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.