RecruitingPhase 2NCT05940961

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

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)

Sponsor

Sheng-Li Xue, MD

Enrollment

42 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

ALL MRD-positive Hematopoietic Stem Cell Transplantation

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.

Eligibility

Min Age: 15 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing inotuzumab ozogamicin (a targeted therapy that delivers chemotherapy directly to cancer cells) in patients with acute lymphoblastic leukemia (ALL) whose cancer has come back (at the molecular level) after a stem cell transplant. **You may be eligible if...** - You are between 15 and 65 years old - You have B-cell ALL (a type of blood cancer) that expresses a protein called CD22 - Your cancer has shown signs of returning after a stem cell transplant, detected by a very sensitive test (MRD positive) - If you have Philadelphia chromosome-positive ALL, you must have already tried at least one second-generation TKI (targeted drug) **You may NOT be eligible if...** - You have T-cell ALL or ALL that does not express CD22 - You have not had a prior stem cell transplant - You have liver disease or other organ dysfunction - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInotuzumab Ozogamicin

intravenous infusion: Cycle 1: D1 0.8mg/m2, D8 0.5mg/m2, D15 0.5mg/m2, if the MRD turn negative, cycle 2: D1 0.5mg/m2, D8 0.5mg/m2, D15 0.5mg/m2， if not，cycle 2: D1 0.8mg/m2, D8 0.5mg/m2, D15 0.5mg/m2