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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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%

Headache

23%

Nausea

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%

Epistaxis

12%

Pruritus

12%

Arthralgia

12%

Hypocalcaemia

12%

Aspartate aminotransferase increased

12%

Tachycardia

12%

Abdominal pain

12%

Hypertension

12%

Decreased appetite

12%

Hypoalbuminaemia

10%

Fatigue

10%

Hypomagnesaemia

10%

Hypoxia

10%

Alanine aminotransferase increased

10%

Pain in extremity

10%

Upper respiratory tract infection

10%

Constipation

Erythema

Myalgia

Oropharyngeal pain

Petechiae

Face oedema

Back pain

Hypotension

Pain

Insomnia

Oedema peripheral

Dry skin

Rhinitis

Thrombocytopenia

Immunoglobulins decreased

Lymphocyte count decreased

Nasal congestion

Blood fibrinogen decreased

Haematuria

Seizure

Allergy to immunoglobulin therapy

Febrile neutropenia

Sinus tachycardia

Abdominal pain upper

Chills

Hyperglycaemia

Hyperuricaemia

Anxiety

Herpes zoster

Sepsis

Acute lymphocytic leukaemia recurrent

Encephalopathy

Bacterial infection

Device related infection

Bone marrow failure

Pneumonia

Aspergillus infection

Dysarthria

Infection

Candida infection

Dyskinesia

Haemophagocytic lymphohistiocytosis

Facial paralysis

Somnolence

Multiple organ dysfunction syndrome

Hepatocellular injury

Hepatosplenomegaly

Alternaria infection

Central nervous system infection

Cerebral fungal infection

Enterococcal infection

Dehydration

Hypernatraemia

Hyponatraemia

Cellulitis

Cellulitis orbital

Chest X-ray abnormal

Leukocytosis

Left ventricular dysfunction

Drug withdrawal syndrome

Influenza

Meningitis aseptic

Periorbital cellulitis

Pneumonia haemophilus

Respiratory syncytial virus infection

Septic shock

Sinusitis

Tonsillitis

Viral upper respiratory tract infection

Splinter

Lactic acidosis

Tumour lysis syndrome

Joint effusion

B precursor type acute leukaemia

Leukaemia

Neoplasm progression

Depressed level of consciousness

Completed suicide

Confusional state

Disorientation

Hallucination

Irritability

Jugular vein thrombosis

Tremor

Agitation

100%

80%

60%

40%

20%

Study treatment Arm

All Subjects - CTL019

ELARA Trial Design

1Treatment groups

Experimental Treatment

Group I: CTL019Experimental Treatment1 Intervention

All patients who received tisagenlecleucel infusion.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,256 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being given the opportunity to participate in this particular clinical trial?

"As of now, this study has stopped recruiting patients. It was originally posted on November 12th, 2018 and edited for the last time on November 2nd, 2022. There are currently 1761 studies looking for participants with lymphoma and 18 trials searching for individuals to test tisagenlecleucel."

Answered by AI

What are the long-term risks associated with tisagenlecleucel?

"Tisagenlecleucel's safety is based on data from Phase 2 trials, which only provide evidence of its safety and not efficacy."

Answered by AI

How many different locations are participating in this research project?

"There are a total of 9 clinical trial sites currently enrolling patients, with locations in Oregon, Texas, Illinois, and 6 other states."

Answered by AI

What are researchers aiming to accomplish with this trial?

"The primary outcome of this study, which will be monitored over the course of 2 years, is CRR as assessed by an independent review committee. Additional secondary outcomes include T1/2; a cellular kinetic parameter defined as The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood, humoral immunogenicity which is measured in terms of antibody titers specific to the tisagenlecleucel molecule prior to and following infusion., and summary PRO scores as captured by the EQ-5D-3L quality of life questionnaire."

Answered by AI

Are there any ongoing or previous research projects regarding tisagenlecleucel?

"Tisagenlecleucel is being studied in 18 different ongoing clinical trials, 2 of which are Phase 3 studies. The majority of research centres for tisagenlecleucel are located in Washington D.C., but there are a total of 331 locations where tisagenlecleucel clinical trials are taking place."

Answered by AI

Can people with the condition still enroll in this clinical study?

"This particular study is not seeking new patients at this time, as the last update was on November 2nd, 2022. However, there are 18 other trials for tisagenlecleucel actively enrolling participants and 1761 studies involving lymphoma, follicular that are currently looking for candidates."

Answered by AI

Recent research and studies

Nature MedicineJournal

Tisagenlecleucel in Adult Relapsed or Refractory Follicular Lymphoma: The Phase 2 ELARA Trial

Fowler, Nathan Hale, Michael Dickinson, Martin Dreyling, Joaquin Martinez-Lopez, Arne Kolstad, Jason Butler, Monalisa Ghosh, et al.. 2021. “Tisagenlecleucel in Adult Relapsed or Refractory Follicular Lymphoma: The Phase 2 ELARA Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01622-0.

Blood AdvancesJournal

Efficacy Comparison of Tisagenlecleucel Vs Usual Care in Patients with Relapsed or Refractory Follicular Lymphoma

Salles, Gilles A., Stephen J. Schuster, Martin Dreyling, Luca Fischer, John Kuruvilla, Piers EM Patten, Bastian von Tresckow, et al.. 2022. “Efficacy Comparison of Tisagenlecleucel Vs Usual Care in Patients with Relapsed or Refractory Follicular Lymphoma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2022008150.

clinicaltrials.govStudy

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma

2018. "Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03568461.

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