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CAR T-cell Therapy
Tisagenlecleucel for Acute Lymphoblastic Leukemia (CASSIOPEIA 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
CD19 expressing B-cell Acute Lymphoblastic Leukemia
B. ALT ≤ 5 times ULN for age
Must not have
Has had treatment with any prior anti-CD19 therapy 9. Treatment with any prior gene or engineered T cell therapy
Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the efficacy and safety of tisagenlecleucel in children and young adults with B-ALL who have received first-line treatment and are EOC MRD positive.
Who is the study for?
This trial is for young people (1-25 years old) with high-risk B-cell Acute Lymphoblastic Leukemia who've had first-line treatment but still have detectable cancer cells. They need to be generally healthy, with good heart, kidney, liver function and no severe breathing problems.
What is being tested?
The study tests the safety and effectiveness of a therapy called tisagenlecleucel (CTL019) in patients after initial leukemia treatments. It's an open-label phase II trial where participants are closely monitored over several phases including screening, pre-treatment, treatment & follow-up.
What are the potential side effects?
While not specified here, similar therapies can cause flu-like symptoms, risk of infection, allergic reactions during infusion and potential impact on blood counts or organ functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia is CD19 positive.
Select...
My ALT levels are within 5 times the normal limit for my age.
Select...
My first treatment for B-ALL didn't clear all cancer cells, showing more than 0.01% MRD.
Select...
I can do most activities but may need help.
Select...
My AST levels are within 5 times the normal limit for my age.
Select...
I am between 1 and 25 years old.
Select...
My heart is strong enough for treatment, as confirmed by recent tests.
Select...
I experience little to no shortness of breath.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously received treatments targeting CD19 or gene/T cell therapies.
Select...
My cancer cells have fewer than 44 chromosomes or a low DNA index.
Select...
My bone marrow is still highly affected by cancer after initial treatment.
Select...
I have been diagnosed with Burkitt's lymphoma/leukemia.
Select...
My leukemia has not fully responded to initial treatment or is progressing.
Select...
I have been treated with tyrosine kinase inhibitors before.
Select...
My leukemia is Philadelphia chromosome positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission
Overall Survival (OS) rate
Secondary study objectives
AUC 0 - 29d; cellular kinetic parameter of tisagenlecleucel
AUC0-29d and 84d; cellular kinetic parameter of tisagenlecleucel
AUC0-Tmax; cellular kinetic parameter of tisagenlecleucel
+27 moreSide effects data
From 2020 Phase 3 trial • 69 Patients • NCT0312393943%
Cytokine release syndrome
35%
Pyrexia
30%
Hypogammaglobulinaemia
25%
Diarrhoea
23%
Headache
23%
Nausea
20%
White blood cell count decreased
20%
Hypokalaemia
20%
Cough
20%
Anaemia
19%
Vomiting
16%
Neutrophil count decreased
14%
Hypophosphataemia
14%
Neutropenia
14%
Platelet count decreased
14%
Rash
13%
Nasopharyngitis
12%
Hypoalbuminaemia
12%
Hypocalcaemia
12%
Tachycardia
12%
Arthralgia
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Epistaxis
12%
Decreased appetite
12%
Hypertension
12%
Pruritus
10%
Alanine aminotransferase increased
10%
Upper respiratory tract infection
10%
Hypoxia
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%
Tumour lysis syndrome
1%
Candida infection
1%
Aspergillus infection
1%
Central nervous system infection
1%
Hepatosplenomegaly
1%
Joint effusion
1%
Cellulitis
1%
Pneumonia haemophilus
1%
Septic shock
1%
B precursor type acute leukaemia
1%
Leukaemia
1%
Neoplasm progression
1%
Depressed level of consciousness
1%
Drug withdrawal syndrome
1%
Cellulitis orbital
1%
Jugular vein thrombosis
1%
Hyponatraemia
1%
Meningitis aseptic
1%
Periorbital cellulitis
1%
Splinter
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single dose of CTL019Experimental Treatment1 Intervention
Based on the subject's weight one of two possible dose ranges will be prepared for the subject:
Subjects ≤ 50 kg: 0.2 to 5.0 x 10(6) CAR-positive viable T cells per kg body weight
OR
Subjects \> 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells
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?
Children's Oncology GroupNETWORK
460 Previous Clinical Trials
239,877 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,913 Previous Clinical Trials
4,253,042 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer cells have fewer than 44 chromosomes or a low DNA index.My leukemia is CD19 positive.My bone marrow is still highly affected by cancer after initial treatment.I have been diagnosed with Burkitt's lymphoma/leukemia.My leukemia has not fully responded to initial treatment or is progressing.I have previously received treatments targeting CD19 or gene/T cell therapies.My ALT levels are within 5 times the normal limit for my age.I have a genetic condition related to bone marrow failure, but not Down syndrome.My lungs work well enough for treatment.My first treatment for B-ALL didn't clear all cancer cells, showing more than 0.01% MRD.I can do most activities but may need help.My organs are working well.My kidney function is appropriate for my age and gender.My AST levels are within 5 times the normal limit for my age.I am between 1 and 25 years old.My heart is strong enough for treatment, as confirmed by recent tests.I've had up to 3 rounds of standard chemo for my B-ALL.I experience little to no shortness of breath.I have been treated with tyrosine kinase inhibitors before.My leukemia is Philadelphia chromosome positive.There may be other specific requirements or restrictions for participation in the study that will be explained to you.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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