A Retrospective Study of Patients With Leukemia Relapse in the CNS Treated With CAR T Cells
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT04158011
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to clear CNS leukemia. Nevertheless, these cases are sparse and have never been reported collectively.
Here, we aim to retrospectively assess toxicity and long term outcome of patients treated with CAR T cells for CNS relapse of ALL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Prior diagnosis of B-cell acute lymphoblastic leukemia involving the central nervous system
- Treatment with CAR T cells (either on a clinical trial or commercial use) due to this indication
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival 6 months Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis
- Secondary Outcome Measures
Name Time Method Incidence of CAR-related CRS or ICANS per ASCTC guidelines 2 months Number of patients and average grade of cytokine-release syndrome and immune-effector cell associated neurotoxicity syndrome within 2 months after CAR treatment, according to ASCTC guidelines (Lee et al, BBMT 2019)
Leukemia-free survival 6 months Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis
CNS-leukemia free survival 6 months Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis
Trial Locations
- Locations (1)
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel