Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
Study Details
Study Description
Brief Summary
A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Inotuzumab Ozogamicin Each subject will be treated with Inotuzumab Ozogamicin |
Drug: Inotuzumab ozogamicin
Patients who achieved CR/CRi had their InO dose at 1.5mg/m2 per cycle (28days/cycle), with 0.5mg/m2 administered on days 1, 8, and 15.
Patients received treatment for up to two cycles in the absence of disease progression or unacceptable toxicity.
Other Names:
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Outcome Measures
Primary Outcome Measures
- MRD negativity rate within the first treatment cycle [At the end of Cycle 1 (each cycle is 28 days)]
MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Secondary Outcome Measures
- Complete MRD response rates [At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)]
Complete MRD response is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
- Duration of MRD negativity rate [From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)]
The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status.
- MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively [From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)]
The variation of MRD level from baseline to post cycle 1, cycle 2, respectively
- Relapse-free Survival (RFS) [Up to 5 years from enrollment]
RFS is defined as the time from the date of CR until the date of relapse or death
- Overall Survival (OS) [Up to 5 years from enrollment]
OS is defined as the time from enrollment to date of death due to any cause.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
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Age ≥18 years
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ECOG PS score: 0 to 2
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Functions of the main organs are normal, if the following criteria are met:
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Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)
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Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN
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Serum creatinine ≤ 1.5 × ULN
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Creatinine clearance ≥ 30 ml/min
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No active or co-existing malignancy with a life expectancy of less than 12 months
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Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.
Exclusion Criteria:
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Mixed lineage leukemia
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Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
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Patients with severe and / or uncontrolled diseases, such as:
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Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
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Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
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Known to be human immunodeficiency virus positive (HIV+)
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Active and uncontrolled disease/infection as judged by the treating physician
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Active central nervous system (CNS) or extramedullary disease
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Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study
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Pregnant or nursing women
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Unable or unwilling to sign the consent form
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Monoclonal antibodies therapy within 2 weeks before study entry
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Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry
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Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO
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Patients in other situations who are evaluated by the investigator to be ineligible
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institute of Hematology & Blood Diseases Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIT2022011-EC-2