RecruitingNot ApplicableNCT06481241

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

77 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R)B-ALL. The available data suggest that the advancement of immunotherapy from relapsed/refractory (R/R) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing chemotherapy combined with CAR-T cell therapy — a treatment where your own immune cells are engineered to attack cancer — in adults newly diagnosed with a specific type of leukemia called Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph- B-ALL). **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Ph-negative B-cell ALL (confirmed by bone marrow and genetic testing) - Your leukemia cells express the CD19 protein - Your heart, liver, kidneys, and other organs are functioning adequately - Your expected survival is greater than 3 months **You may NOT be eligible if...** - You have previously been treated for this leukemia - You have significant organ failure - You are pregnant or breastfeeding - 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

COMBINATION_PRODUCTCAR-T cells

CAR-T cells as consolidation therapy

DRUGVenetoclax

VEN


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

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NCT06481241


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