Using Inotuzumab Ozogamicin to treat MRD-positive ALL after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of Inotuzumab Ozogamicin in patients with minimal residual disease (MRD) recurrence following hematopoietic stem cell transplantation (HSCT) for acute lymphoblastic leukemia (ALL). It focuses on patients aged 15 to 65 diagnosed with CD22+ B-ALL who have experienced MRD recurrence. The study aims to determine if this treatment can help achieve MRD-negative status, which is associated with better long-term survival outcomes. The approach builds on previous findings that suggest Inotuzumab Ozogamicin can improve remission rates and overall survival in similar patient populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged ≥ 15 and ≤ 65 years.
2. Patients diagnosed with CD22+ B-ALL according to 2023 NCCN Acute Lymphoblasts Leukaemias diagnosis standard.
3. CD22+ B-ALL patients with MRD recurrence after HSCT. Ph+ ALL patients were eligible if treatment with 1 or more second-generation BCR::ABL1 tyrosine kinase inhibitors (TKIs) had failed,
4. ECOG performance status score less than 3.
5. Expected survival time #3 months.
6. Patients without serious heart, lung, liver, or kidney disease.
7. Ability to understand and voluntarily provide informed consent.

Exclusion Criteria:

1. Patients who are allergic to the study drug or drugs with similar chemical structures.
2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
3. Active infection.
4. Active bleeding.
5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
7. Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
8. Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
9. Surgery on the main organs within the past six weeks.
10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
11. Patients who have received organ transplants (excepting bone marrow transplantation).
12. Patients not suitable for the study according to the investigator's assessment.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Sheng-Li Xue, MD
• Email: slxue@suda.edu.cn
• Phone: 0086-0512-67781139

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.