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

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    42
  • sponsor
    Sheng-Li Xue, MD
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Updated on 12 July 2023
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Summary

As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high.

MRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.

Description

As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high.

MRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. INO-VATE confirmed that Inotuzumab Ozogamicin can be used to achieve high remission (CR/CRi) and MRD-negative rates, serving as an effective bridge to HSCT, and it is associated with increased OS and PFS in patients with R/R BCP ALL. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.

Details
Condition MRD-positive After HSCT of ALL Patients
Age 15years - 65years
Treatment Inotuzumab Ozogamicin
Clinical Study IdentifierNCT05940961
SponsorSheng-Li Xue, MD
Last Modified on12 July 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients aged ≥ 15 and ≤ 65 years
Patients diagnosed with CD22+ B-ALL according to 2023 NCCN Acute Lymphoblasts Leukaemias diagnosis standard
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
ECOG performance status score less than 3
Expected survival time #3 months
Patients without serious heart, lung, liver, or kidney disease
Ability to understand and voluntarily provide informed consent

Exclusion Criteria

Patients who are allergic to the study drug or drugs with similar chemical structures
Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
Active infection
Active bleeding
Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
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
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)
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
Surgery on the main organs within the past six weeks
Drug abuse or long-term alcohol abuse that would affect the evaluation results
Patients who have received organ transplants (excepting bone marrow transplantation)
Patients not suitable for the study according to the investigator's assessment
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