RecruitingPhase 2NCT06554626

Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL

The Regimen of Blinatumomab and Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating Precursor B Cell Acute Lymphoblastic Leukemia: A Phase II, Single Arm and Multicenter Study


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

20 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study,we propose a treatment approach that combines Blinatumomab and Venetoclax sequenced with Inotuzumab Ozogamicin in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new combination approach for adults aged 40 and older who are newly diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) — an aggressive blood cancer — and whose cancer does not carry the Philadelphia chromosome (a specific genetic change). The treatment sequence uses blinatumomab and venetoclax together, followed by inotuzumab ozogamicin, aiming to achieve deep remission without needing intensive chemotherapy. **You may be eligible if...** - You are 40 or older with newly diagnosed Philadelphia chromosome-negative B-cell ALL - Your performance status is acceptable (ECOG 0-2) with a life expectancy of at least 3 months - Your heart, liver, and kidney functions are adequate **You may NOT be eligible if...** - Your leukemia has spread to the brain or spinal cord - You have had another cancer in the past 5 years (except localized thyroid or skin cancers) - You have heart failure with an ejection fraction below 45% - You have HIV or other serious active health conditions 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

DRUGDexamethasone

Glucocorticoids

DRUGBlinatumomab

Bi-specific anti CD19/CD3 antibody

DRUGVenetoclax

BCL-2 inhibotor

DRUGInotuzumab ozogamicin

a humanized monoclonal antibody-drug conjugate targeting CD22

DRUGMethotrexate

antifolate antineoplastic drug

DRUGPegaspargase

antitumor drug

DRUGCytarabine

Pyrimidine, antimetabolites


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06554626