Combining low-dose chemotherapy with immuno-targeted drugs for elderly patients with Ph-negative B-ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.