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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158011
Recruitment Status : Active, not recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Elad Jacoby, MD, 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.


Condition or disease
Acute Lymphoblastic Leukemia

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: CARs for CNS-Leukemia Relapse: A Retrospective International Study
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : January 1, 2021


Group/Cohort
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



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months ]
    Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis


Secondary Outcome Measures :
  1. Incidence of CAR-related CRS or ICANS per ASCTC guidelines [ Time Frame: 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)

  2. Leukemia-free survival [ Time Frame: 6 months ]
    Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis

  3. CNS-leukemia free survival [ Time Frame: 6 months ]
    Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158011


Locations
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Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
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Responsible Party: Elad Jacoby, MD, Head, Pediatric Cancer Immunotherapy, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04158011    
Other Study ID Numbers: SMC 6257-19
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elad Jacoby, MD, Sheba Medical Center:
CAR T cells
CNS leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases