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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 below
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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.
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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 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

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 more

Side effects data

From 2020 Phase 3 trial • 69 Patients • NCT03123939
43%
Cytokine release syndrome
35%
Pyrexia
30%
Hypogammaglobulinaemia
25%
Diarrhoea
23%
Headache
23%
Nausea
20%
Cough
20%
Hypokalaemia
20%
White blood cell count decreased
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%
Upper respiratory tract infection
10%
Hypoxia
10%
Alanine aminotransferase increased
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%
Candida infection
1%
Neoplasm progression
1%
Aspergillus infection
1%
Hyponatraemia
1%
B precursor type acute leukaemia
1%
Central nervous system infection
1%
Hepatosplenomegaly
1%
Joint effusion
1%
Jugular vein thrombosis
1%
Cellulitis
1%
Pneumonia haemophilus
1%
Septic shock
1%
Leukaemia
1%
Drug withdrawal syndrome
1%
Depressed level of consciousness
1%
Cellulitis orbital
1%
Meningitis aseptic
1%
Periorbital cellulitis
1%
Splinter
1%
Tumour lysis syndrome
1%
Facial paralysis
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
2,911 Previous Clinical Trials
4,250,579 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
~14 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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