NCT06387121 Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL
| NCT ID | NCT06387121 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 53 participants in total. It began in 2024-04-02 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. ≥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.
Contact & Investigator
Jianxiang Wang
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT06387121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Precursor Cell Lymphoblastic Leukemia-Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06387121 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06387121 currently recruiting?
Yes, NCT06387121 is actively recruiting participants. Contact the research team at wangjx@ihcams.ac.cn for enrollment information.
Where is the NCT06387121 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06387121 clinical trial?
NCT06387121 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Jianxiang Wang at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 53 participants.
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