Actively Recruiting
Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-17
53
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia according to WHO 2016 criteria
- CD22 positive tumor cells
- 18 years of age or older
- Estimated survival of at least 3 months
- Consent given and use of effective contraception for men and women of childbearing potential
- Understanding and signing of informed consent forms and agreement to follow study requirements
You will not qualify if you...
- Diagnosis of Burkitt lymphoma or leukemia
- Acute leukemias of ambiguous lineage
- Pregnant women
- Severe uncontrolled active infection
- Previous history of chronic liver disease such as cirrhosis or venous occlusive liver disease or sinus obstruction syndrome
- History of significant heart rhythm problems including ventricular arrhythmia, unexplained syncope, sinoatrial or higher degree atrioventricular block, or chronic bradycardia unless a permanent pacemaker is implanted
- New or chronic hepatitis B or C infection or known HIV positive status
- Psychiatric disorders likely to prevent completing treatment or giving informed consent
- Other conditions deemed unsuitable for the study by the investigator
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, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jianxiang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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