Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for elderly or unfit patients who have just been diagnosed with a specific type of leukemia called Ph-negative B-cell acute lymphoblastic leukemia (B-ALL). The researchers want to see if combining low-dose chemotherapy with immuno-targeted drugs can help improve the chances of patients going into complete remission, which means no signs of the disease, and ultimately increase their overall survival. The trial is currently looking for participants aged 60 and older, or younger patients with certain health issues that make traditional chemotherapy risky.

Eligible participants will receive a combination of therapies that aim to make their treatment safer and more effective. They will need to meet specific criteria, such as having positive tumor cells and being able to provide informed consent. Throughout the study, participants can expect regular monitoring and support. This trial is important because it seeks to find better treatment options for those who might not tolerate standard therapies well and could significantly impact the lives of patients with this challenging condition.

Gender

ALL

Eligibility 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. ≥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.