Tisagenlecleucel In Primary CNS Lymphoma (NCT04134117) | Clinical Trial Compass
CompletedPhase 1
Tisagenlecleucel In Primary CNS Lymphoma
United States13 participantsStarted 2019-01-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Primary CNS Lymphoma in high risk elderly patients
* New diagnosis of primary CNS lymphoma.
* Voluntarily sign informed consent form(s)
* ≥60 years of age at the time of signing informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* Have failed or are unable to tolerate definitive first-line methotrexate based therapy as defined by:
* Grade 3+ AKI and/or transaminitis preventing repeat treatment exposure and/or,
* Failure to achieve a complete response (per IPCG) following two cycles of first line therapy,
\--- Definitive first-line therapies must include high dose methotrexate-based therapy but may also include temozolomide, high dose cytarabine, pemetrexed, lenalidomide, ibrutinib and rituximab.
* Whole-brain irradiation, lenalidomide monotherapy and ibrutinib monotherapy are considered first line therapy if patient was not eligible for methotrexate-based chemotherapy at time of initial treatment but now meets study eligibility criteria.
* Adequate absolute lymphocyte count (ALC \> 500 cells/ul) within one week of apheresis.
* Adequate bone marrow function defined by absolute neutrophil count (ANC) \>1000 cells/mm3without growth factor support, and untransfused platelet count \>50,000 mm3 within 7 days.
* Left ventricular ejection fraction \>40%
* Adequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \<2.5 × upper limit of normal (ULN) and direct bilirubi…
What they're measuring
1
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteriaand ASTCT 2018 (CRS/NT)