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Clinical Trials in China / NCT05456698
Active, not recruiting Phase 2

Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy

NCT05456698 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2022-10-18
Last updated
2026-04-16

Condition(s) studied

Acute Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

Inotuzumab ozogamicin

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Age ≥18 years 3. ECOG PS score: 0 to 2 4. Functions of the main organs are normal, if the following criteria are met: 1. Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN) 2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN 3. Serum creatinine ≤ 1.5 × ULN 4. Creatinine clearance ≥ 30 ml/min 5. No active or co-existing malignancy with a life expectancy of less than 12 months 6. Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed. Exclusion Criteria: 1. Mixed lineage leukemia 2. Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS) 3. Patients with severe and / or uncontrolled diseases, such as: 1. 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) 2. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis 3. Known to be human immunodeficiency virus positive (HIV+) 4. Active and uncontrolled disease/infection as judged by the treating physician 5. Active central nervous system (CNS) or extramedullary disease 6. 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 4. Pregnant or nursing women 5. Unable or unwilling to sign the consent form 6. Monoclonal antibodies therapy within 2 weeks before study entry 7. Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry 8. Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO 9. Patients in other situations who are evaluated by the investigator to be ineligible

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital Tianjin Tianjin Municipality

More Institute of Hematology & Blood Diseases Hospital, China trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05456698 on ClinicalTrials.gov ↗ ← All trials in China