A Retrospective Study of Patients With Leukemia Relapse in the CNS Treated With CAR T Cells

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

CARs for CNS-Leukemia Relapse: A Retrospective International Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04158011
• Other study ID #: SMC 6257-19
• Status: Active, not recruiting
• Start date: November 6, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2019
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 1, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis	6 months
Secondary	Incidence of CAR-related CRS or ICANS per ASCTC guidelines	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)	2 months
Secondary	Leukemia-free survival	Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis	6 months
Secondary	CNS-leukemia free survival	Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis	6 months