Actively Recruiting
Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
82
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia
- Presence of CD19 expression on leukemia blasts
- Expected survival time greater than 3 months
- Adequate organ function including specific limits on bilirubin, liver enzymes, creatinine, amylase, lipase, alkaline phosphatase, electrolytes, and heart function
- Provided written informed consent before any screening procedures
You will not qualify if you...
- Lymphoid blast crisis of chronic myelocytic leukemia (CML)
- Previous or ongoing systemic anti-ALL therapy except appropriate pre-treatment
- History of myocardial infarction within 12 months or significant cardiac diseases
- Uncontrolled serious infections
- Known HIV positive status
- History of acute or chronic pancreatitis
- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
- Another malignancy diagnosed and treated within 5 years or residual disease from prior malignancy except certain skin or carcinoma in situ cancers
- Female patients who are pregnant or breastfeeding
- Active central nervous system or extramedullary involvement with ALL
- Poorly controlled diabetes (HbA1c >7.5%)
- Serious psychiatric illness affecting treatment completion
- Other conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020
Actively Recruiting
Research Team
J
Jianxiang Wang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here