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CAR T-cell Therapy

CTL019 for Acute Lymphoblastic Leukemia (ELIANA 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, m6, m12, m24, m60
Awards & highlights

ELIANA Trial Summary

This trial is testing a new treatment for kids with a certain type of leukemia that has come back or didn't respond to previous treatment.

Eligible Conditions
  • Acute Lymphoblastic Leukemia

ELIANA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, m6, m12, m24, m60
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, m6, m12, m24, m60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Overall Remission Rate (ORR) as Determined by Independent Review Committee (IRC) Assessment.
Secondary outcome measures
Bone Marrow MRD Status by Flow Cytometry Per IRC Assessment
Develop a Score Utilizing Clinical and Biomarker Data and Assess Its Ability for Early Prediction of Cytokine Release Syndrome (CRS)
Duration of Remission (DOR)
+30 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%
Arthralgia
12%
Pruritus
12%
Hypocalcaemia
12%
Aspartate aminotransferase increased
12%
Tachycardia
12%
Abdominal pain
12%
Hypertension
12%
Decreased appetite
12%
Hypoalbuminaemia
10%
Hypoxia
10%
Fatigue
10%
Hypomagnesaemia
10%
Pain in extremity
10%
Alanine aminotransferase increased
10%
Upper respiratory tract infection
10%
Constipation
9%
Myalgia
9%
Oropharyngeal pain
9%
Petechiae
9%
Face oedema
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%
Blood fibrinogen decreased
6%
Haematuria
6%
Seizure
6%
Allergy to immunoglobulin therapy
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%
Aspergillus infection
1%
Dysarthria
1%
Infection
1%
Candida infection
1%
Haemophagocytic lymphohistiocytosis
1%
Facial paralysis
1%
Somnolence
1%
Dyskinesia
1%
Multiple organ dysfunction syndrome
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

ELIANA Trial Design

1Treatment groups
Experimental Treatment
Group I: Single dose of CTL019Experimental Treatment1 Intervention
Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTL019
2017
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,278 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
New England Journal of MedicineJournal
Tisagenlecleucel in Children and Young Adults with B-cell Lymphoblastic Leukemia
Maude, Shannon L., Theodore W. Laetsch, Jochen Buechner, Susana Rives, Michael Boyer, Henrique Bittencourt, Peter Bader, et al.. 2018. “Tisagenlecleucel in Children and Young Adults with B-cell Lymphoblastic Leukemia”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1709866.
Journal for ImmunoTherapy of CancerJournal
Pooled Safety Analysis of Tisagenlecleucel in Children and Young Adults with B Cell Acute Lymphoblastic Leukemia
Levine, John E, Stephan A Grupp, Michael A Pulsipher, Andrew C Dietz, Susana Rives, G Douglas Myers, Keith J August, et al.. 2021. “Pooled Safety Analysis of Tisagenlecleucel in Children and Young Adults with B Cell Acute Lymphoblastic Leukemia”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2020-002287.
The Lancet OncologyJournal
Patient-reported Quality of Life After Tisagenlecleucel Infusion in Children and Young Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukaemia: A Global, Single-arm, Phase 2 Trial
Laetsch, Theodore W, Gary Douglas Myers, André Baruchel, Andrew C Dietz, Michael A Pulsipher, Henrique Bittencourt, Jochen Buechner, et al.. 2019. “Patient-reported Quality of Life After Tisagenlecleucel Infusion in Children and Young Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukaemia: A Global, Single-arm, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30493-0.
Blood AdvancesJournal
Practical Guidelines for Monitoring and Management of Coagulopathy Following Tisagenlecleucel CAR T-cell Therapy
Buechner, Jochen, Stephan A. Grupp, Hidefumi Hiramatsu, David T. Teachey, Susana Rives, Theodore W. Laetsch, Gregory A. Yanik, et al.. 2021. “Practical Guidelines for Monitoring and Management of Coagulopathy Following Tisagenlecleucel CAR T-cell Therapy”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020002757.
~8 spots leftby Apr 2025
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