RecruitingPhase 2NCT06387121

Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL

Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Adult Patients With Ph-negative B-cell Acute Lymphocytic Leukemia: A Prospective, Single-arm Clinical Study


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

53 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens. In recent years, tumor immunotherapy has demonstrated promising safety and efficacy profiles in refractory or relapsed Ph- B-ALL across a wide spectrum of adult ages. These findings suggest that broader application of immunotherapy may represent a critical strategy to improve survival in this population. In this study, we propose a regimen that combines immuno-targeted agents with low-intensity chemotherapy for newly diagnosed adult patients with Ph- B-ALL. Our primary objective is to increase the rate of measurable residual disease (MRD)-negative complete remission (CR) following induction therapy, reduce the risk of relapse, and ultimately enhance overall survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a gentler, lower-dose chemotherapy regimen combined with two newer targeted drugs (inotuzumab and blinatumomab) for adults newly diagnosed with a specific type of leukemia called Ph-negative B-cell acute lymphoblastic leukemia (ALL), a fast-growing blood cancer. **You may be eligible if...** - You are 18 or older - You have a new diagnosis of Ph-negative B-cell ALL - Your cancer cells are CD22-positive (a protein on the surface of cancer cells) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have Burkitt lymphoma/leukemia or a mixed-lineage leukemia - You are pregnant - You have a severe uncontrolled infection - You have a history of serious liver disease (cirrhosis or vein blockage in the liver) - You have significant heart rhythm problems - You have active hepatitis B, hepatitis C, or HIV - You have a psychiatric disorder that would prevent completing treatment 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

DRUGVincristine

Anti-tumor alkaloids

DRUGCyclophosphamide

Alkylating agent

DRUGDexamethasone

Glucocorticoids

DRUGVenetoclax

Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

DRUGInotuzumab ozogamicin

A humanized monoclonal antibody-drug conjugate targeting CD22

DRUGBlinatumomab

Bi-specific anti-CD19/CD3 antibodies

DRUG6-mercaptopurine

Cell cycle-specific antitumor drug

DRUGMethotrexate

Antifolate antineoplastic drug

DRUGCytarabine

Pyrimidine antimetabolites

DRUGPrednisone

Glucocorticoids


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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NCT06387121


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