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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My tisagenlecleucel treatment was not made to commercial standards.
Select...
I am eligible for tisagenlecleucel treatment according to my country's health guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
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 • NCT0312393943%
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%
Pruritus
12%
Epistaxis
12%
Arthralgia
12%
Hypocalcaemia
12%
Aspartate aminotransferase increased
12%
Tachycardia
12%
Abdominal pain
12%
Hypertension
12%
Decreased appetite
12%
Hypoalbuminaemia
10%
Hypomagnesaemia
10%
Hypoxia
10%
Fatigue
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
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
2,859 Previous Clinical Trials
4,198,044 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Group B: r/r LBCL
- Group 2: Group C: r/r NHL
- Group 3: Group A: pALL
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals does this trial aim to achieve?
"The primary objective of this clinical trial, as measured by the sponsor Novartis Pharmaceuticals, is to evaluate the percentage of Adverse Events (AEs) in participants over a Screening to EOT (Month 3)/Early Withdrawal time frame. Additionally, this trial will also be measuring secondary objectives including the ORR in Group A (pALL), the Overall Response Rate in Group B (LBCL), and the Overall Remission Rate in Group A (pALL) in Part 1."
Answered by AI
Can people still sign up to be a part of this medical research?
"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov from October 17th, 2020. The trial was initially posted on November 21st, 2019."
Answered by AI
When might the FDA potentially approve CTL019?
"CTL019 has been studied in multiple Phase 3 trials, meaning that there is data supporting both its efficacy and safety. As such, our team has rated it a 3 on our safety scale."
Answered by AI
Does this trial break new ground in the medical community?
"As of now, there are 18 ongoing clinical trials involving CTL019 across 115 cities and 22 countries. The first trial began in 2015 and completed Phase 2 drug approval in 97 participants. Since then, 12 additional trials have completed."
Answered by AI
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