Tisagenlecleucel In Primary CNS Lymphoma

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    6
  • sponsor
    Matthew J. Frigault, M.D.
Updated on 24 February 2022
platelet count
renal function
methotrexate
cytarabine
rituximab
ejection fraction
anticoagulants
direct bilirubin
growth factor
lenalidomide
pemetrexed
neutrophil count
aptt
temozolomide
nervous
ibrutinib

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.

Description

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

Details
Condition Primary CNS Lymphoma, Refractory Primary CNS Lymphoma, Relapsed Primary CNS Lymphoma
Treatment Tisagenlecleucel
Clinical Study IdentifierNCT04134117
SponsorMatthew J. Frigault, M.D.
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Primary CNS Lymphoma in high risk elderly patients
New diagnosis of primary CNS lymphoma
Voluntarily sign informed consent form(s)
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 bilirubin <1.5 ULN
Adequate renal function defined by creatinine clearance >30 ml/min using the Cockcroft-Gault formula
International ratio (INR) or partial thromboplastin time (PTT) <1.5 ULN, unless on a stable dose of anticoagulant for a thromboembolic event
The effects of tisagenlecleucel T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis for at least 1-year post tisagenlecleucel infusion and until CAR T cells are no longer present by qPCR on two consecutive tests. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to leukapheresis and until 4 months after tisagenlecleucel T cells administration
Ability and willingness to adhere to the study visit schedule and all protocol requirements
Relapsed/Refractory Primary CNS Lymphoma
Diagnosis of relapsed/refractory PCNSL having received at least one prior line of CNS directed therapy
Voluntarily sign informed consent form(s)
years of age at the time of signing informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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, untransfused platelet count >50,000 mm3, and untransfused hemoglobin >9 g/dL
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 bilirubin <1.5 ULN
Adequate renal function defined by creatinine clearance >30 ml/min using the Cockcroft-Gault formula
International ratio (INR) or partial thromboplastin time (PTT) <1.5 ULN, unless on a stable dose of anticoagulant for a thromboembolic event
The effects of tisagenlecleucel T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis for at least 1-year post tisagenlecleucel infusion and until CAR T cells are no longer present by qPCR on two consecutive tests. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to leukapheresis and until 4 months after tisagenlecleucel T cells administration
Ability and willingness to adhere to the study visit schedule and all protocol requirements
Inclusion Criteria for Lymphodepletion/Cell Infusion
No Active, uncontrolled, systemic bacterial, viral, or fungal infection
Adequate renal function defined by creatinine clearance >30 ml/min using the Cockcroft-Gault formula

Exclusion Criteria

Prior treatment with an any investigational cellular therapy
Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine). Systemic steroids are allowed up to a dose of dexamethasone 4mg daily or equivalent
Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant
Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and/or recent significant traumatic injury
Active, uncontrolled, systemic bacterial, viral, or fungal infection
Active hepatitis B or hepatitis C infection
HIV infection
Subjects with a history of class III or IV congestive heart failure or non- ischemic cardiomyopathy
Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy
Pregnant or lactating women
Live virus vaccines within 2 weeks prior to planned start of lymphodepleting chemotherapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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