Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL

Launched by SHENG-LI XUE, MD · Jul 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option called Inotuzumab Ozogamicin for patients with a type of blood cancer known as Acute Lymphoblastic Leukemia (ALL) who have Minimal Residual Disease (MRD) after undergoing a procedure called hematopoietic stem cell transplantation (HSCT). MRD means that, even after treatment, there are still small amounts of cancer cells left in the body, which can lead to the cancer coming back. The goal of this study is to see how effective and safe Inotuzumab Ozogamicin is for helping patients with MRD after their transplant, as many patients face a high risk of relapse.

To be eligible for this trial, participants must be between 15 and 65 years old and have a specific type of ALL that tests positive for a protein called CD22. They should also have experienced a recurrence of MRD after their transplant. Additionally, candidates must be in fairly good health overall, without serious heart or organ diseases. If you or someone you know qualifies and chooses to participate, the study will involve receiving the new treatment and monitoring for its effects and any side effects. This trial is currently recruiting participants, and it's an important step in finding better treatments for patients facing MRD after HSCT.

Gender

ALL

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.