Combining chemotherapy with CAR-T cell therapy for newly diagnosed adult patients with Philadelphia Chromosome Negative ALL
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia
This study is testing if combining CAR-T cell therapy with chemotherapy can help adults newly diagnosed with Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | blinatumomab, inotuzumab, CAR-T, chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06481241 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of using CAR-T cell therapy in combination with chemotherapy for adult patients newly diagnosed with Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia (ALL). The approach aims to enhance the depth of remission achieved through chemotherapy, potentially leading to improved survival rates and quality of life. Patients who achieve complete remission will receive CAR-T cell therapy as a consolidation treatment, which may reduce the need for additional chemotherapy cycles and associated toxicities. The CAR-T cells used are second-generation CD19 CAR-T cells, administered in a single infusion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed Philadelphia Chromosome Negative ALL who have achieved complete remission with chemotherapy.
Not a fit: Patients with Burkitt lymphoma or those with other specific exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with Philadelphia Chromosome Negative ALL.
How similar studies have performed: Other studies have shown promising results with CAR-T cell therapy in relapsed/refractory B-ALL, suggesting potential success in this frontline setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification 2. Male or female patients aged 18 years or older 3. CD19 expression on blasts 4. Expected survival time greater than 3 months 5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45% 6. Subject has provided written informed consent prior to any screening procedure Exclusion Criteria: 1. Burkitt lymphoma/leukemia 2. Acute Leukemia of Ambiguous Lineage 3. Clinical manifestations of active CNS or extramedullary involvement with ALL 4. Female patients who are pregnant or breast feeding 5. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment 6. Known HIV seropositivity 7. Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal) or sinus block, history of chronic bradycardia with a high degree of atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted) 8. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment 9. Other conditions assessed by the investigators to be inappropriate for this study
Where this trial is running
Tianjin
- Institute of Hematology & Blood Diseases Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Jianxiang Wang, Dr — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Jianxiang Wang, Dr
- Email: wangjx@ihcams.ac.cn
- Phone: 86-22-23608451
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.