None listed
Conditions
Interventions
Drug :
1. Screening CART-19 candidate: R/R BCP-ALL, with age >= 15years old
- Bone marrow evaluation for diagnosis relapse
- PET-CT evaluation, if extramedullary relapse is suspicious
2. Apheresis f
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Patients aged 15 to under 75 years with relapsed or refractory acute lymphoblastic leukemia (ALL) who meet the insurance criteria for current CD19-targeted CAR-T therapy or are eligible for clinical trial enrollment for anti-CD19 CAR-T therapy, with an expected life expectancy of at least 3 months. - Indications for CAR-T therapy: 1. As second-line treatment (first salvage therapy) if the patient fails to achieve remission with first-line treatment. 2. As second-line treatment (first salvage therapy) if the patient relapses after allogeneic hematopoietic stem cell transplantation. 3. As third-line treatment (second salvage therapy) if the patient relapses or is refractory after two or more systemic treatments. 2. In the case of relapse, expression of CD19 and CD22 must be confirmed to be 20% or more in identified leukemia cell markers. 3. At the time of enrollment review, liver function (total bilirubin = 3.0 mg/dL; AST and/or ALT < 5 x UNL) and renal function (CCr = 30 mL/min) must be maintained without disease-related associations (however, if bilirubin elevation is due to Gilbert's syndrome or if the investigator determines liver function test elevations are due to leukemia/lymphoma involvement, registration may be possible even if the above conditions are exceeded). 4. ECOG performance scale < 3. 5. Patients who agree to the protocol and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Patients with confirmed central nervous system (CNS) involvement of leukemia cells (Patients who have been treated and are in complete remission can be enrolled if there is no evidence of CNS involvement 4 weeks after treatment). 2. Patients who test positive for hepatitis B virus (HBsAg positive, =1.0 S/CO), hepatitis C virus (anti-HCV Ab positive, =1.0 S/CO), or human immunodeficiency virus (HIV Ag/Ab positive, =1.0 S/CO). 3. Patients who were non-responsive to prior inotuzumab ozogamicin treatment. 4. Patients with uncontrolled bleeding symptoms. 5. Patients with uncontrolled infections. 6. Patients with other uncontrolled severe diseases or medical conditions (including those with hypersensitivity to Besponsa, progressive liver cancer, cirrhosis, nodular hyperplasia, active hepatitis, veno-occlusive liver disease, renal failure requiring dialysis, severe heart disease, etc.). 7. Pregnant women, breastfeeding women, and women of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response (CR+CRi+CRp) Assessment Post-INOTUZUMAB Ozogamicin (INO) and Prior to CAR-T Therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the reduction in leukemia cell burden before CART-19 therapy. ;Assess the incidence and severity of adverse events: Hepatic Veno-Occlusive Disease (VOD) Cytokine Release Syndrome (CRS) Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Other frequent hematologic and non-hematologic toxicities: Assess using the Common Terminology Criteria for Adverse Events (CTCAE) criteria to determine the frequency and severity. ;Evaluate minimal residual disease (MRD) before and after CART-19 therapy. ;Clinical outcome: Determine the 1-year overall survival rate, relapse rate, and relapse-free survival rate. | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Ho Yoon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed