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

NCT04158011 | Unknown

• 1 other identifier: SMC 6257-19
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

CAR T cells; CNS leukemia

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis

  6 months

Secondary Outcomes (3)

• Incidence of CAR-related CRS or ICANS per ASCTC guidelines

  2 months

• Leukemia-free survival

  6 months

• CNS-leukemia free survival

  6 months

Study Arms (2)

CNS ALL at lymphodepletion

Patients with active CNS leukemia at the time of lymphodepletion

CNS ALL at inclusion

Patients who were referred to CAR T-cells with CNS disease, which was cleared by the time of lymphodepletion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective review of patients with CNS - involvement of B-cell ALL, treated with CAR T cells targeting CD19 of either an institutional-based clinical trial, a pharma-based clinical trial or commercial product.

You may qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Pediatric Cancer Immunotherapy

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: November 6, 2019
• Primary Completion: March 1, 2020
• Study Completion: January 1, 2021
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

IL (1)