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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

Tracking Information
First Submitted Date November 6, 2019
First Posted Date November 8, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date November 6, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2019)
Overall survival [ Time Frame: 6 months ]
Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 7, 2019)
  • 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)
  • Leukemia-free survival [ Time Frame: 6 months ]
    Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis
  • CNS-leukemia free survival [ Time Frame: 6 months ]
    Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study of Patients With Leukemia Relapse in the CNS Treated With CAR T Cells
Official Title CARs for CNS-Leukemia Relapse: A Retrospective International Study
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acute Lymphoblastic Leukemia
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 7, 2019)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2021
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT04158011
Other Study ID Numbers SMC 6257-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Elad Jacoby, MD, Sheba Medical Center
Study Sponsor Sheba Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Sheba Medical Center
Verification Date November 2019