← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

ELARA Trial 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.Check my eligibility
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.See study design
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.

ELARA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Follicular Lymphoma has returned or is not responding to treatment.

ELARA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
Secondary outcome measures
AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel
AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel
Cellular Immunogenicity
+14 more

Side effects data

From 2020 Phase 3 trial • 69 Patients • NCT03123939
43%
Cytokine release syndrome
35%
Pyrexia
30%
Hypogammaglobulinaemia
25%
Diarrhoea
23%
Nausea
23%
Headache
20%
Hypokalaemia
20%
Anaemia
20%
Cough
20%
White blood cell count decreased
19%
Vomiting
16%
Neutrophil count decreased
14%
Hypophosphataemia
14%
Neutropenia
14%
Rash
14%
Platelet count decreased
13%
Nasopharyngitis
12%
Pruritus
12%
Epistaxis
12%
Hypocalcaemia
12%
Arthralgia
12%
Aspartate aminotransferase increased
12%
Tachycardia
12%
Abdominal pain
12%
Hypertension
12%
Decreased appetite
12%
Hypoalbuminaemia
10%
Hypomagnesaemia
10%
Pain in extremity
10%
Fatigue
10%
Hypoxia
10%
Alanine aminotransferase increased
10%
Upper respiratory tract infection
10%
Constipation
9%
Oropharyngeal pain
9%
Myalgia
9%
Face oedema
9%
Petechiae
9%
Back pain
9%
Erythema
9%
Hypotension
7%
Pain
7%
Insomnia
7%
Oedema peripheral
7%
Dry skin
7%
Rhinitis
7%
Thrombocytopenia
7%
Immunoglobulins decreased
7%
Lymphocyte count decreased
6%
Allergy to immunoglobulin therapy
6%
Haematuria
6%
Blood fibrinogen decreased
6%
Seizure
6%
Nasal congestion
6%
Febrile neutropenia
6%
Sinus tachycardia
6%
Abdominal pain upper
6%
Chills
6%
Hyperglycaemia
6%
Hyperuricaemia
6%
Anxiety
4%
Herpes zoster
4%
Sepsis
4%
Acute lymphocytic leukaemia recurrent
3%
Encephalopathy
3%
Bacterial infection
3%
Device related infection
3%
Bone marrow failure
3%
Pneumonia
1%
Infection
1%
Dysarthria
1%
Candida infection
1%
Aspergillus infection
1%
Facial paralysis
1%
Haemophagocytic lymphohistiocytosis
1%
Multiple organ dysfunction syndrome
1%
Dyskinesia
1%
Somnolence
1%
Hepatocellular injury
1%
Hepatosplenomegaly
1%
Alternaria infection
1%
Central nervous system infection
1%
Cerebral fungal infection
1%
Enterococcal infection
1%
Dehydration
1%
Hypernatraemia
1%
Hyponatraemia
1%
Cellulitis
1%
Cellulitis orbital
1%
Chest X-ray abnormal
1%
Leukocytosis
1%
Left ventricular dysfunction
1%
Drug withdrawal syndrome
1%
Influenza
1%
Meningitis aseptic
1%
Periorbital cellulitis
1%
Pneumonia haemophilus
1%
Respiratory syncytial virus infection
1%
Septic shock
1%
Sinusitis
1%
Tonsillitis
1%
Viral upper respiratory tract infection
1%
Splinter
1%
Lactic acidosis
1%
Tumour lysis syndrome
1%
Joint effusion
1%
B precursor type acute leukaemia
1%
Leukaemia
1%
Neoplasm progression
1%
Depressed level of consciousness
1%
Completed suicide
1%
Confusional state
1%
Disorientation
1%
Hallucination
1%
Irritability
1%
Jugular vein thrombosis
1%
Tremor
1%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Subjects - CTL019

ELARA 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
2,866 Previous Clinical Trials
4,199,228 Total Patients Enrolled

Media Library

Follicular Lymphoma Research Study Groups: CTL019
Follicular Lymphoma Clinical Trial 2023: tisagenlecleucel Highlights & Side Effects. Trial Name: NCT03568461 — Phase 2
~15 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