Combining low-dose chemotherapy with immuno-targeted drugs for elderly patients with Ph-negative B-ALL
Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Adult Patients With Ph-negative B-cell Acute Lymphocytic Leukemia: A Prospective, Single-arm Clinical Study
This study is testing a new treatment that combines low-dose chemotherapy with targeted drugs to see if it can help older patients with a specific type of leukemia feel better and stay in remission longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Inotuzumab, Blinatumomab, CAR-T, chimeric antigen receptor, methotrexate |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06387121 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial investigates the efficacy and safety of a treatment regimen that combines low-dose chemotherapy with immuno-targeted drugs for newly diagnosed elderly or unfit patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL). The study aims to enhance the measurable residual disease (MRD)-negative complete remission rate following induction therapy and reduce the risk of relapse. Patients will receive a combination of Inotuzumab ozogamicin, Venetoclax, and low-dose chemotherapy, followed by Blinatumomab and additional therapies as needed. The trial will enroll 53 participants and will follow them for at least five years post-treatment.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed patients aged 60 and older, or those aged 18 to 59 with significant comorbidities that preclude intensive chemotherapy.
Not a fit: Patients with Burkitt lymphoma, acute leukemias of ambiguous lineage, or severe uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for elderly or unfit patients with Ph-negative B-ALL.
How similar studies have performed: Other studies have shown promising results with immunotherapy approaches in similar patient populations, indicating potential for success in this novel combination treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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. ≥18 years of age 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.
Where this trial is running
Tianjin, Tianjin Municipality
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jianxiang Wang — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Jianxiang Wang
- Email: wangjx@ihcams.ac.cn
- Phone: +862223909120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.