Tisagenlecleucel In Primary CNS Lymphoma
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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
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): 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|