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Tests treatment safety and results for Philadelphia Positive Acute Lymphoblastic Leukemia
Official title Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL
ClinicalTrials.gov ID: NCT06481228
What this study is testing
What is CAR-T cells?
CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for philadelphia positive acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients aged 18 years or older
- Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia
- CD19 expression on blasts
- Expected survival time greater than 3 months
- Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum...
You likely can't join if
- Lymphoid blast crisis of chronic myelocytic leukemia (CML)
- Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment)
- Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina...
- Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
- Known HIV seropositivity
- History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis
See the full eligibility criteria
- Male or female patients aged 18 years or older
- Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia
- CD19 expression on blasts
- Expected survival time greater than 3 months
- 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...
- Subject has provided written informed consent prior to any screening procedure
- Lymphoid blast crisis of chronic myelocytic leukemia (CML)
- Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment)
- 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...
- Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
- Known HIV seropositivity
- History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis
- Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL)
- 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...
- Female patients who are pregnant or breast feeding
- Clinical manifestations of active CNS or extramedullary involvement with ALL
- Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded
- Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
- Other conditions assessed by the investigators to be inappropriate for this study
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.