RecruitingPhase 2NCT06742515

Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL

Blinatumomab Combined With Reduced-dose Chemotherapy 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

Oct 17, 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 Reduced-dose Chemotherapy 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: 15 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining blinatumomab (a drug that helps the immune system attack leukemia cells) with reduced-dose chemotherapy is safe and effective for newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) that does not carry the Philadelphia chromosome mutation. **You may be eligible if...** - You are between 15 and 59 years old - You have newly diagnosed B-cell acute lymphoblastic leukemia (Philadelphia chromosome-negative) - You are in reasonably good physical condition (ECOG 0–2) - Your expected survival is at least 2 months - Your organ function is adequate **You may NOT be eligible if...** - The leukemia has spread to your brain or spinal fluid - You have severe heart, liver, kidney, or lung problems - Your heart pumping function (LVEF) is below 45% - You have had another cancer in the past 5 years - You have HIV 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBlinatumomab plus Reduced-dose Chemotherapy

Cycle 1: Reduced VCP on day1, IV and Blinatumomab for 2 weeks, IV. Cycle 2: Blinatumomab for 2 weeks, IV and Venetoclax for 2 weeks, oral.


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06742515


Related Trials