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CAR T-cell Therapy

Tisagenlecleucel for Acute Lymphoblastic Leukemia

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 reinfusion up to 9 months
Awards & highlights

Summary

This trial found that tisagenlecleucel was safe and effective in patients with ALL who had B cell recovery.

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~reinfusion up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and reinfusion up to 9 months 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 Patients Who Establish B Cell Aplasia Within 9 Months of Reinfusion
Secondary outcome measures
Complete Response (CR) or Complete Response With Incomplete Blood Count Recovery (CRi) by Day
Overall Survival (OS)
Participants With an Event

Side effects data

From 2022 Phase 2 trial • 115 Patients • NCT02445248
48%
Anaemia
41%
Cytokine release syndrome
36%
White blood cell count decreased
35%
Neutrophil count decreased
33%
Platelet count decreased
31%
Diarrhoea
30%
Pyrexia
29%
Nausea
24%
Hypotension
24%
Fatigue
23%
Hypokalaemia
21%
Headache
18%
Neutropenia
17%
Hypophosphataemia
17%
Constipation
17%
Hypomagnesaemia
17%
Cough
15%
Oedema peripheral
14%
Arthralgia
14%
Dyspnoea
13%
Decreased appetite
13%
Thrombocytopenia
13%
Upper respiratory tract infection
12%
Weight decreased
12%
Dizziness
12%
Chills
10%
Blood creatinine increased
10%
Anxiety
10%
Tachycardia
10%
Febrile neutropenia
9%
Hypogammaglobulinaemia
9%
Pain in extremity
9%
Urinary tract infection
8%
Hyponatraemia
8%
Vomiting
8%
Nasopharyngitis
8%
Pneumonia
8%
Influenza like illness
8%
Abdominal pain
7%
Insomnia
7%
Hypoxia
7%
Asthenia
7%
Sinusitis
7%
Confusional state
6%
Myalgia
6%
Back pain
6%
Stomatitis
6%
Blood immunoglobulin G decreased
6%
Lymphocyte count decreased
6%
Influenza
5%
Acute kidney injury
5%
Oropharyngeal pain
5%
Dry mouth
5%
Night sweats
5%
Hypocalcaemia
5%
Pain
5%
Pleural effusion
5%
Rash
3%
Clostridium difficile infection
3%
Pancytopenia
3%
Multiple organ dysfunction syndrome
3%
Sepsis
3%
Encephalopathy
3%
Myelodysplastic syndrome
3%
Prostate cancer
2%
Pulmonary embolism
2%
Bone marrow failure
2%
Gastrointestinal haemorrhage
2%
Pneumocystis jirovecii pneumonia
2%
Staphylococcal infection
2%
Respiratory failure
2%
Dehydration
2%
Respiratory tract infection
2%
Infection
1%
Syncope
1%
Pneumonitis
1%
Urosepsis
1%
C-reactive protein increased
1%
Invasive ductal breast carcinoma
1%
Tumour associated fever
1%
Somnolence
1%
Metabolic encephalopathy
1%
Cardiac arrest
1%
Blood bilirubin increased
1%
Refractory cytopenia with multilineage dysplasia
1%
Chronic kidney disease
1%
Haemophagocytic lymphohistiocytosis
1%
Vaginal infection
1%
Haematemesis
1%
Pancreatitis acute
1%
Hepatic failure
1%
Lymphadenopathy
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Cardiopulmonary failure
1%
Vertigo
1%
Face oedema
1%
Systemic infection
1%
Myopathy
1%
Large intestinal obstruction
1%
Melaena
1%
Cholecystitis acute
1%
Cardiac failure congestive
1%
Bronchopulmonary aspergillosis
1%
Upper limb fracture
1%
Tumour lysis syndrome
1%
Pulmonary haemorrhage
1%
Atypical pneumonia
1%
Infusion related reaction
1%
Duodenal ulcer haemorrhage
1%
Anal fissure
1%
Candida infection
1%
Cerebral toxoplasmosis
1%
Corynebacterium infection
1%
Malignant melanoma
1%
Acute polyneuropathy
1%
Bronchitis
1%
Acute myeloid leukaemia
1%
Cerebral haemorrhage
1%
Cystitis haemorrhagic
1%
Lower respiratory tract infection
1%
Pneumonia aspiration
1%
Liver function test increased
1%
Neuroendocrine carcinoma
1%
Demyelinating polyneuropathy
1%
Status epilepticus
1%
Asphyxia
1%
Escherichia infection
1%
Pseudomonas infection
1%
Hypercalcaemia
1%
Polyarthritis
1%
Tumour haemorrhage
1%
Ischaemic cerebral infarction
1%
Mental status changes
1%
Urinary tract obstruction
1%
Deep vein thrombosis
1%
Allergic bronchitis
1%
Pharyngeal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisagenlecleucel - All Patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: TisagenlecleucelExperimental Treatment1 Intervention
Tisagenlecleucel Cell Dispersion for Infusion given once during the study. The approved dose range for tisagenlecleucel is: 0.2 to 5.0×106 CAR positive viable T cells / kg for patients' ≤ 50 kg body weight or 0.1 to 2.5×108 CAR-positive viable T cells for patients \> 50 kg body weight.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisagenlecleucel
2019
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,999 Total Patients Enrolled
~1 spots leftby Sep 2025
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