Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Elderly or Unfit Patients With Ph-negative B-cell Acute Lymphocytic Leukemia: A Prospective, Single-arm Clinical Study

IIT2023060-EC-1

In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL), despite the achievements of chemotherapy and immunotherapy, the therapeutic outcomes are unsatisfactory in elderly or unfit patients. In recent years, tumor immunotherapy has demonstrated a high safety and efficacy profile in refractory Ph- B-ALL patients. These findings suggest that the advancement of immunotherapy application may be an important approach to improve patient survival. In this study, we propose a treatment approach that combines immuno-targeted drugs with low-dose chemotherapy for newly diagnosed elderly or unfit patients with Ph- B-ALL, aiming to enhance the measurable residual disease (MRD)-negative complete remission (CR) rate measured through flow cytometry following induction therapy, reduce the risk of relapse, and ultimately improve patients' overall survival.

2024-04-15

2026-12-01

2028-12-31

Not yet recruiting

Early phase I

53

Inclusion Criteria: 1. Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria 2. CD22 positive tumor cells 3. ≥60 years of age, or 18 to 59 years of age, with at least one of the following: Eastern Cooperative Oncology Group (ECOG) performance status of 2 - 3; severe heart, lung, liver, or kidney disease; presence of comorbidities that are not suitable for intensive chemotherapy in the physician's judgment 4. Estimated survival ≥3 months 5. Consent and effective contraception for men and women of childbearing potential 6. Understanding and signing of informed consent forms and agreement to comply with study requirements. Exclusion Criteria: 1. Burkitt lymphoma/leukemia 2. acute leukemias of ambiguous lineage 3. pregnant women 4. severe uncontrolled active infection 5. previous history of chronic liver disease (e.g. cirrhosis) or venous occlusive liver disease (VOD) or sinus obstruction syndrome (SOS) 6. History of clinically significant ventricular arrhythmia, syncope of unknown origin (not vasovagal) or sinoatrial block or higher degree atrioventricular (AV) block Chronic bradycardia state (unless permanent pacemaker implanted) 7. New or chronic hepatitis B or C infection (positive for hepatitis B surface antigen and anti-hepatitis C antibody, respectively) or known HIV seropositivity. HIV testing may need to be performed according to local regulations or practices 8. Psychiatric disorders likely to prevent the subject from completing treatment or informed consent 9. Other conditions considered unsuitable for the study by the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 53, 'type': 'ESTIMATED'}}

2024-04-26