RecruitingPhase 2NCT06427330

Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

21 participants

Start Date

Jul 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-dose inotuzumab ozogamicin — an antibody-drug that targets leukemia cells — given after a stem cell transplant can prevent acute lymphoblastic leukemia (ALL) from relapsing (coming back) in high-risk patients. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CD22-positive acute lymphoblastic leukemia (B-cell ALL) - You have undergone a stem cell transplant (from a donor or your own cells) - It has been at least 60 days since your transplant - Your leukemia was high-risk, relapsed/refractory, or had detectable residual cancer (MRD positive) before transplant - Your donor chimerism is above 99% (meaning the transplant has successfully engrafted) - Your blood counts have recovered adequately after transplant - Your overall health is adequate (ECOG ≤ 2) **You may NOT be eligible if...** - Your leukemia is progressing at the time of enrollment - You have significant ongoing side effects from prior treatment - Your organ function is too impaired to tolerate the study drug 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

1. st dose is given after D+60:inotuzumab 0.3mg/m2 2. nd dose is given after 1 month:inotuzumab 0.6mg/m2


Locations(1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

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NCT06427330


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