Tisagenlecleucel In Primary CNS Lymphoma

NCT04134117 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 19-319
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Primary CNS Lymphoma; Relapsed Primary CNS Lymphoma; Primary CNS Lymphoma

Keywords

Primary CNS Lymphoma; Refractory Primary CNS Lymphoma; Relapsed Primary CNS Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteriaand ASTCT 2018 (CRS/NT)

  12 Months

Secondary Outcomes (6)

• Objective disease response to tisagenlecleucel

  1 Month

• Objective disease response to tisagenlecleucel

  3 Months

• Objective disease response to tisagenlecleucel

  6 months

• Objective disease response to tisagenlecleucel

  12 months

• Overall Survival Rate

  15 years

Study Arms (1)

Tisagenlecleucel

EXPERIMENTAL

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.

Biological: Tisagenlecleucel

Interventions

Tisagenlecleucel BIOLOGICAL

One time single predetermined dose level CAR-positive T cells will be utilized based on the FDA approved product label.

Also known as: KYMRIAH

Tisagenlecleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 bilirubin \<1.5 × ULN
• Adequate renal function defined by creatinine clearance \>30 ml/min using the Cockcroft-Gault formula

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matthew J. Frigault, M.D.: lead
• Novartis: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

tisagenlecleucel

Study Officials

• Matthew J. Frigault, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: January 1, 2019
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)