Phase 3
Completed N=307
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT01564784 ↗Enrolled (actual)
307
Serious AEs
51.1%
Results posted
Jan 2018
Primary outcomePrimary: Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) — 80.7; 29.4 Percentage of Participants — p=<0.0001
◆ Published Evidence
Established
75citations · ~15 / year
Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia.
Summary
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
Linked Publications (5)
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Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia.
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Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy, and Safety by Baseline CD22.
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Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia.
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Association of leukemic molecular profile with efficacy of inotuzumab ozogamicin in adults with relapsed/refractory ALL.
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Time to First Subsequent Salvage Therapy in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin in the Phase III INO-VATE Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) |
80.7; 29.4 | <0.0001 sig |
| PRIMARY Overall Survival (OS) |
7.7; 6.2 | 0.0105 sig |
| SECONDARY Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) |
5.4; 3.5 | 0.0021 sig |
| SECONDARY Progression-Free Survival (PFS) |
5.0; 1.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) |
42.7; 11.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) |
78.4; 28.1 | <0.0001 sig |
| SECONDARY Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) |
3.7; 18.2 | 0.3168 |
| SECONDARY Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing |
211; 57.9; 308 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score |
0.48; 0.32; 3.15; -13.33; 5.33; 0.00 | 0.0139 sig |
| SECONDARY Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score |
0.00; 0.02; 0.01; -0.08; 0.04; 0.00 | 0.1710 |
| SECONDARY Change From Baseline in EQ-5D VAS |
5.81; 5.90; 8.13; 19.67; 7.13; 44.00 | 0.1172 |
| SECONDARY Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT |
22.8; 8.6 | — |
Eligibility Criteria
Inclusion Criteria
- CD22 expression
- Adequate liver and renal functions
Exclusion Criteria
- Isolated extramedullary disease
- Active Central Nervous System [CNS] disease
Data sourced from ClinicalTrials.gov (NCT01564784) and the linked publication. 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.