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

A Multicenter Prospective Clinical Study of Inotuzumab Ozogamicin (INO) in the Treatment of Minimal Residual Disease Recurrent After Hematopoietic Stem Cell Transplantation of Acute Lymphoblastic Leukemia (ALL)

This study is testing if a new treatment called Inotuzumab Ozogamicin can help young adults with a type of leukemia who have had a stem cell transplant and are facing a return of their disease.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 15 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Drugs / interventions: Inotuzumab
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05940961 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 15 to 65 with CD22+ B-ALL who have experienced MRD recurrence after HSCT.

Not a fit: Patients with serious comorbidities, active infections, or those who are allergic to the study drug may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve long-term survival rates for patients with MRD-positive ALL after HSCT.

How similar studies have performed: Previous studies have shown promising results with Inotuzumab Ozogamicin in similar contexts, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Sheng-Li Xue, MD

Conditions: ALL, MRD-positive, Hematopoietic Stem Cell Transplantation