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CAR T-cell Therapy

Tisagenlecleucel Safety for Cancer

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.
Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region.
Must not have
Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
Patients with primary central nervous system (CNS) lymphoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Summary

This trial will study the safety of a drug that doesn't meet specification for release. It will specifically study the safety of the drug in Japanese patients in two parts. Part one will also study the efficacy of the drug.

Who is the study for?
This trial is for patients with certain types of B-cell lymphoma or acute lymphoblastic leukemia whose tisagenlecleucel treatment doesn't meet commercial standards but isn't unsafe. They must understand the study, not have hepatitis B/C, CNS lymphoma, HIV, uncontrolled infections, be pregnant/nursing, or have conditions affecting safety assessment.
What is being tested?
The trial tests the safety and some efficacy of CTL019 (tisagenlecleucel) that's out of specification for commercial release in Japan. Part 1 looks at both safety and key effects; Part 2 focuses on safety within approved use.
What are the potential side effects?
While specific side effects aren't listed here, similar treatments can cause immune reactions, infusion-related symptoms, fatigue, blood abnormalities and increase infection risk. Patients with known hypersensitivity to related drugs are excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tisagenlecleucel treatment was not made to commercial standards.
Select...
I am eligible for tisagenlecleucel treatment according to my country's health guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have active Hepatitis B or C.
Select...
I have been diagnosed with lymphoma in my brain or spinal cord.
Select...
I am HIV positive.
Select...
I do not have any ongoing infections or inflammations that aren't under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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 participants with Adverse Events (AEs)
Secondary outcome measures
Part 1: Overall Remission Rate in Group A (pALL)
Part 1: Overall Response Rate in Group B (LBCL)

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%
White blood cell count decreased
20%
Cough
20%
Hypokalaemia
20%
Anaemia
19%
Vomiting
16%
Neutrophil count decreased
14%
Hypophosphataemia
14%
Neutropenia
14%
Platelet count decreased
14%
Rash
13%
Nasopharyngitis
12%
Tachycardia
12%
Hypocalcaemia
12%
Hypoalbuminaemia
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%
Hyponatraemia
1%
Central nervous system infection
1%
Joint effusion
1%
Hepatosplenomegaly
1%
Candida infection
1%
Cellulitis
1%
Pneumonia haemophilus
1%
Septic shock
1%
Jugular vein thrombosis
1%
Drug withdrawal syndrome
1%
Aspergillus infection
1%
B precursor type acute leukaemia
1%
Neoplasm progression
1%
Depressed level of consciousness
1%
Cellulitis orbital
1%
Leukaemia
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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group C: r/r NHLExperimental Treatment1 Intervention
Adult patients with r/r NHL in consistent with the Health Authority approved indication in the package insert for CTL019 in Japan whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
Group II: Group B: r/r LBCLExperimental Treatment1 Intervention
Adult patients with r/r LBCL including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, that is consistent with the Health Authority-approved indication in the package insert for CTL019 in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
Group III: Group A: pALLExperimental Treatment1 Intervention
Pediatric/young adult patients with r/r pALL who meet the indication in the Health Authority-approved CTL019 package insert in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
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
2,889 Previous Clinical Trials
4,203,201 Total Patients Enrolled

Media Library

Diffuse Large B-Cell Lymphoma Research Study Groups: Group B: r/r LBCL, Group C: r/r NHL, Group A: pALL
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: CTL019 Highlights & Side Effects. Trial Name: NCT04094311 — Phase 3
CTL019 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04094311 — Phase 3
~22 spots leftby Apr 2025
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