RecruitingNot ApplicableNCT06481228

Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL

Efficacy and Safety of Molecular Targeted Therapy Combined With Chemotherapy and Sequential CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Positive B-cell Acute Lymphoblastic Leukemia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

82 participants

Start Date

Jun 4, 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 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+ ALL patients achieving complete remission (CR) with overembatinib, venetoclax and reduced-intensity 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 a combination of targeted therapy (TKI drugs), chemotherapy, and CAR-T cell therapy — a treatment where your own immune cells are engineered to fight cancer — for adults newly diagnosed with a specific type of leukemia called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Ph+ ALL (confirmed by genetic testing showing the Philadelphia chromosome) - Your leukemia cells express the CD19 protein (which the CAR-T cells target) - 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 been previously treated for this leukemia - You have significant organ failure or severe heart problems - You are pregnant or breastfeeding - You have active infections like HIV or hepatitis 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

BCL2 inhibitor

DRUGOlverembatinib

TKI


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

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NCT06481228


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