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Compares treatment options for B-cell Acute Lymphoblastic Leukemia
Official title Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients
ClinicalTrials.gov ID: NCT06343090
What this study is testing
What is CD19 CAR T-cell?
CD19 CAR T-cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell 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
- This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 70
You may be able to join if
- Only patients who meet all the following criteria can be included in the group:
- Patients who were diagnosed as primary refractory or relapsed B-ALL. (Criterion-reference: NCCN, version 2.2023); All the patients matched the...
- Age from 1 to 70 years old;
- No serious allergic constitution;
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;
You likely can't join if
- Patients with at least one of the following conditions are excluded:
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Diffuse intravascular coagulation;
See the full eligibility criteria
- Only patients who meet all the following criteria can be included in the group:
- Patients who were diagnosed as primary refractory or relapsed B-ALL. (Criterion-reference: NCCN, version 2.2023); All the patients matched the diagnostic criteria of ALL according to the NCCN guideline (≥20% bone marrow...
- Age from 1 to 70 years old;
- No serious allergic constitution;
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;
- Have life expectancy of at least 60 days based on investigator's judgement;
- Voluntary informed consent is signed by self-aware patients aged 8-70 years and by legal representatives (guardians) of pediatric patients under 18 years of age.
- Patients with at least one of the following conditions are excluded:
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Diffuse intravascular coagulation;
- Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
- Sepsis or other uncontrolled infection;
- Uncontrolled diabetes mellitus;
- Severe psychological disorder;
- Obvious cranial lesions by cranial MRI;
- More than 20 leukemic cells/μL in cerebrospinal fluid;
- More than 30% leukemic cells in the peripheral blood;
- Organ recipients;
- Pregnant or breastfeeding;
- Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 1 year to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.