Tisagenlecleucel In Primary CNS Lymphoma
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|ClinicalTrials.gov Identifier: NCT04134117|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : January 13, 2020
In this study, is researching the safety of tisagenlecleucel in participants with primary central nervous system lymphoma. .
-The name of the study intervention is tisagenlecleucel.
|Condition or disease||Intervention/treatment||Phase|
|Primary CNS Lymphoma Refractory Primary CNS Lymphoma Relapsed Primary CNS Lymphoma||Biological: Tisagenlecleucel||Phase 1|
This research study is a Pilot Study, which is the first time investigators are examining this intervention in people with primary central nervous system lymphoma.
- The name of the study intervention is tisagenlecleucel. Tisagenlecleucel is an investigational treatment that uses the participants own immune cells, called T cells, to try to kill the cancerous cells
- The research study procedures include screening for eligibility and study treatment including, leukapheresis, evaluations, and follow up visits.
- The study treatment will be one day and participants will be followed for up to 2 years.
- It is expected that about 6 people will take part in this research study
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Tisagenlecleucel, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Patients With Primary Central Nervous System Lymphoma|
|Actual Study Start Date :||December 11, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2022|
Study procedures include screening for eligibility and study treatment including, leukapheresis, evaluations, and follow up visits.
- Tisagenlecleucel will be administered intravenously as a one-time rapid infusion predetermined dose following lymphodepleting chemotherapy.
One time single predetermined dose level CAR-positive T cells will be utilized based on the FDA approved product label.
Other Name: KYMRIAH
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteriaand ASTCT 2018 (CRS/NT) [ Time Frame: 12 Months ]
- Objective disease response to tisagenlecleucel [ Time Frame: 1 Month ]IPCG response criteria.
- Objective disease response to tisagenlecleucel [ Time Frame: 3 Months ]IPCG response criteria.
- Objective disease response to tisagenlecleucel [ Time Frame: 6 months ]IPCG response criteria.
- Objective disease response to tisagenlecleucel [ Time Frame: 12 months ]IPCG response criteria.
- Overall Survival Rate [ Time Frame: 15 years ]Kaplan-Meier method
- Progression Free Survival Rate [ Time Frame: from the date of assignment until the date of first documented progression or date of deathfrom any cause, whichever comes first, assessed up to 100 months ]Kaplan-Meier method
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134117
|Contact: Matthew J. Frigault, MD||(617) email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Matthew J. Frigault, MD 617-643-6175|
|Principal Investigator: Matthew J. Frigault, MD|
|Principal Investigator:||Matthew J. Frigault, MD||Massachusetts General Hospital|