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CAR T-cell Therapy
Tisagenlecleucel for Follicular Lymphoma (ELARA Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
Be older than 18 years old
Must not have
Prior allogeneic hematopoietic stem cell transplant
Prior adoptive T cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment for people with a certain type of lymphoma that has returned or does not respond to other treatments.
Who is the study for?
This trial is for adults with Follicular Lymphoma grades 1, 2, or 3A that hasn't responded to treatment or has come back. Participants must have measurable disease. Those with transformed lymphoma, brain involvement by cancer, previous stem cell transplant, grade 3B lymphoma, or prior gene or anti-CD19 therapy can't join.
What is being tested?
The study tests the effectiveness and safety of a drug called tisagenlecleucel in treating Follicular Lymphoma that's either stopped responding to standard treatments or has returned after treatment.
What are the potential side effects?
Tisagenlecleucel may cause immune system reactions like fever and chills (cytokine release syndrome), nerve damage symptoms (neurotoxicity), allergic reactions during infusion, infections due to weakened immunity, and potential blood production issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Follicular Lymphoma has returned or is not responding to treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stem cell transplant from a donor.
Select...
I have had adoptive T cell therapy before.
Select...
I have received gene therapy before.
Select...
I have received anti-CD19 therapy before.
Select...
My cancer has spread to my brain or spinal cord.
Select...
My condition is Follicular Lymphoma Grade 3B.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
Secondary study objectives
AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel
AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel
Cellular Immunogenicity
+14 moreSide effects data
From 2020 Phase 3 trial • 69 Patients • NCT0312393943%
Cytokine release syndrome
35%
Pyrexia
30%
Hypogammaglobulinaemia
25%
Diarrhoea
23%
Headache
23%
Nausea
20%
White blood cell count decreased
20%
Hypokalaemia
20%
Cough
20%
Anaemia
19%
Vomiting
16%
Neutrophil count decreased
14%
Hypophosphataemia
14%
Neutropenia
14%
Platelet count decreased
14%
Rash
13%
Nasopharyngitis
12%
Hypoalbuminaemia
12%
Hypocalcaemia
12%
Tachycardia
12%
Arthralgia
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Epistaxis
12%
Decreased appetite
12%
Hypertension
12%
Pruritus
10%
Alanine aminotransferase increased
10%
Hypoxia
10%
Upper respiratory tract infection
10%
Fatigue
10%
Constipation
10%
Hypomagnesaemia
10%
Pain in extremity
9%
Face oedema
9%
Back pain
9%
Oropharyngeal pain
9%
Erythema
9%
Hypotension
9%
Myalgia
9%
Petechiae
7%
Pain
7%
Oedema peripheral
7%
Thrombocytopenia
7%
Rhinitis
7%
Immunoglobulins decreased
7%
Lymphocyte count decreased
7%
Insomnia
7%
Dry skin
6%
Nasal congestion
6%
Febrile neutropenia
6%
Sinus tachycardia
6%
Chills
6%
Allergy to immunoglobulin therapy
6%
Abdominal pain upper
6%
Blood fibrinogen decreased
6%
Hyperglycaemia
6%
Seizure
6%
Anxiety
6%
Haematuria
6%
Hyperuricaemia
4%
Herpes zoster
4%
Sepsis
4%
Acute lymphocytic leukaemia recurrent
3%
Bacterial infection
3%
Bone marrow failure
3%
Pneumonia
3%
Device related infection
3%
Encephalopathy
1%
Tumour lysis syndrome
1%
Candida infection
1%
Central nervous system infection
1%
B precursor type acute leukaemia
1%
Hepatosplenomegaly
1%
Joint effusion
1%
Neoplasm progression
1%
Cellulitis
1%
Pneumonia haemophilus
1%
Septic shock
1%
Leukaemia
1%
Depressed level of consciousness
1%
Drug withdrawal syndrome
1%
Jugular vein thrombosis
1%
Hyponatraemia
1%
Periorbital cellulitis
1%
Facial paralysis
1%
Splinter
1%
Aspergillus infection
1%
Meningitis aseptic
1%
Cellulitis orbital
1%
Left ventricular dysfunction
1%
Leukocytosis
1%
Respiratory syncytial virus infection
1%
Sinusitis
1%
Hypernatraemia
1%
Dyskinesia
1%
Multiple organ dysfunction syndrome
1%
Hepatocellular injury
1%
Haemophagocytic lymphohistiocytosis
1%
Dysarthria
1%
Tremor
1%
Completed suicide
1%
Irritability
1%
Alternaria infection
1%
Cerebral fungal infection
1%
Enterococcal infection
1%
Infection
1%
Influenza
1%
Tonsillitis
1%
Viral upper respiratory tract infection
1%
Chest X-ray abnormal
1%
Dehydration
1%
Lactic acidosis
1%
Somnolence
1%
Agitation
1%
Confusional state
1%
Disorientation
1%
Hallucination
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Subjects - CTL019
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CTL019Experimental Treatment1 Intervention
All patients who received tisagenlecleucel infusion.
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,589 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: CTL019
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.