← Back to Search

CAR T-cell Therapy

Tisagenlecleucel for Central Nervous System Lymphoma

Phase 1
Waitlist Available
Led By Matthew J. Frigault, MD
Research Sponsored by Matthew J. Frigault, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial is researching the safety of tisagenlecleucel in people with primary central nervous system lymphoma.

Who is the study for?
This trial is for high-risk elderly patients (60 years or older) with a new diagnosis of primary CNS lymphoma. Participants must have an ECOG performance status of 0-2, indicating they are fully active to limited in physical activity but able to care for themselves. They should not have achieved complete response after two cycles of first-line therapy and must meet specific health criteria like adequate lymphocyte count.Check my eligibility
What is being tested?
The study is examining the safety of tisagenlecleucel, which is a type of immunotherapy treatment designed specifically for individuals with primary central nervous system lymphoma. The focus is on how well these patients tolerate this intervention.See study design
What are the potential side effects?
While the trial's description does not list specific side effects, treatments like tisagenlecleucel can commonly cause reactions related to the immune system such as fever, fatigue, headache, and may affect blood cells leading to increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE Criteriaand ASTCT 2018 (CRS/NT)
Secondary outcome measures
Objective disease response to tisagenlecleucel
Overall Survival Rate
Progression Free Survival Rate

Side effects data

From 2022 Phase 2 trial • 115 Patients • NCT02445248
48%
Anaemia
41%
Cytokine release syndrome
36%
White blood cell count decreased
35%
Neutrophil count decreased
33%
Platelet count decreased
31%
Diarrhoea
30%
Pyrexia
29%
Nausea
24%
Fatigue
24%
Hypotension
23%
Hypokalaemia
21%
Headache
18%
Neutropenia
17%
Constipation
17%
Hypomagnesaemia
17%
Hypophosphataemia
17%
Cough
15%
Oedema peripheral
14%
Arthralgia
14%
Dyspnoea
13%
Decreased appetite
13%
Thrombocytopenia
13%
Upper respiratory tract infection
12%
Chills
12%
Weight decreased
12%
Dizziness
10%
Febrile neutropenia
10%
Tachycardia
10%
Blood creatinine increased
10%
Anxiety
9%
Hypogammaglobulinaemia
9%
Urinary tract infection
9%
Pain in extremity
8%
Hyponatraemia
8%
Abdominal pain
8%
Vomiting
8%
Influenza like illness
8%
Nasopharyngitis
8%
Pneumonia
7%
Insomnia
7%
Asthenia
7%
Sinusitis
7%
Confusional state
7%
Hypoxia
6%
Lymphocyte count decreased
6%
Stomatitis
6%
Influenza
6%
Blood immunoglobulin G decreased
6%
Back pain
6%
Myalgia
5%
Night sweats
5%
Oropharyngeal pain
5%
Dry mouth
5%
Pain
5%
Hypocalcaemia
5%
Acute kidney injury
5%
Pleural effusion
5%
Rash
3%
Myelodysplastic syndrome
3%
Pancytopenia
3%
Prostate cancer
3%
Multiple organ dysfunction syndrome
3%
Clostridium difficile infection
3%
Sepsis
3%
Encephalopathy
2%
Pneumocystis jirovecii pneumonia
2%
Pulmonary embolism
2%
Bone marrow failure
2%
Gastrointestinal haemorrhage
2%
Infection
2%
Respiratory tract infection
2%
Staphylococcal infection
2%
Dehydration
2%
Respiratory failure
1%
Upper limb fracture
1%
Pharyngeal haemorrhage
1%
Infusion related reaction
1%
Haemophagocytic lymphohistiocytosis
1%
Refractory cytopenia with multilineage dysplasia
1%
Syncope
1%
Invasive ductal breast carcinoma
1%
Hepatic failure
1%
Bronchopulmonary aspergillosis
1%
C-reactive protein increased
1%
Urosepsis
1%
Polyarthritis
1%
Pulmonary haemorrhage
1%
Neuroendocrine carcinoma
1%
Lymphadenopathy
1%
Atrial fibrillation
1%
Cardiac arrest
1%
Cardiac failure congestive
1%
Cardio-respiratory arrest
1%
Cardiopulmonary failure
1%
Vertigo
1%
Anal fissure
1%
Duodenal ulcer haemorrhage
1%
Haematemesis
1%
Large intestinal obstruction
1%
Melaena
1%
Pancreatitis acute
1%
Face oedema
1%
Cholecystitis acute
1%
Atypical pneumonia
1%
Bronchitis
1%
Candida infection
1%
Cerebral toxoplasmosis
1%
Corynebacterium infection
1%
Escherichia infection
1%
Lower respiratory tract infection
1%
Pneumonia aspiration
1%
Pseudomonas infection
1%
Systemic infection
1%
Vaginal infection
1%
Blood bilirubin increased
1%
Liver function test increased
1%
Hypercalcaemia
1%
Tumour lysis syndrome
1%
Acute myeloid leukaemia
1%
Tumour associated fever
1%
Acute polyneuropathy
1%
Cerebral haemorrhage
1%
Demyelinating polyneuropathy
1%
Ischaemic cerebral infarction
1%
Metabolic encephalopathy
1%
Somnolence
1%
Status epilepticus
1%
Mental status changes
1%
Chronic kidney disease
1%
Cystitis haemorrhagic
1%
Urinary tract obstruction
1%
Allergic bronchitis
1%
Asphyxia
1%
Pneumonitis
1%
Deep vein thrombosis
1%
Myopathy
1%
Malignant melanoma
1%
Tumour haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisagenlecleucel - All Patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: TisagenlecleucelExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisagenlecleucel
FDA approved

Find a Location

Who is running the clinical trial?

Matthew J. Frigault, M.D.Lead Sponsor
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,029 Total Patients Enrolled
Matthew J. Frigault, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
1 Previous Clinical Trials
6 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tisagenlecleucel In Primary CNS Lymphoma
Matthew J. Frigault, M.D. 2019. "Tisagenlecleucel In Primary CNS Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04134117.
~1 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top