NCT06481228 Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL
| NCT ID | NCT06481228 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Philadelphia Positive Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2026-06-01 |
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.
This trial targets 82 participants in total. It began in 2024-06-04 with a primary completion date of 2026-06-01.
⚠ 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 recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The available data suggest that the advancement of immunotherapy from R/R field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph+ ALL patients achieving complete remission (CR) with overembatinib, venetoclax and reduced-intensity chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged 18 years or older 2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia 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. Lymphoid blast crisis of chronic myelocytic leukemia (CML) 2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment) 3. Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.) 4. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment 5. Known HIV seropositivity 6. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis 7. Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL) 8. Another malignancy diagnosed and treated within 5 years prior to diagnosis or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ that has been completely excised should not be excluded 9. Female patients who are pregnant or breast feeding 10. Clinical manifestations of active CNS or extramedullary involvement with ALL 11. Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded 12. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment 13. Other conditions assessed by the investigators to be inappropriate for this study
Contact & Investigator
Jianxiang Wang, Dr
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT06481228 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Philadelphia Positive Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06481228 currently recruiting?
Yes, NCT06481228 is actively recruiting participants. Contact the research team at wangjx@ihcams.ac.cn for enrollment information.
Where is the NCT06481228 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06481228 clinical trial?
NCT06481228 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Jianxiang Wang, Dr at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 82 participants.
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