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CAR T-cell Therapy
Tisagenlecleucel for Acute Lymphoblastic Leukemia (CASSIOPEIA Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
CASSIOPEIA Trial 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.Check my eligibility
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.See study design
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.
CASSIOPEIA Trial 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.
CASSIOPEIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Free Survival (DFS) rate without censoring for new anticancer therapy, including Stem Cell Transplantation (SCT) while in remission
Overall Survival (OS) rate
Secondary outcome measures
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%
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%
Pruritus
12%
Arthralgia
12%
Hypocalcaemia
12%
Aspartate aminotransferase increased
12%
Tachycardia
12%
Abdominal pain
12%
Hypertension
12%
Decreased appetite
12%
Hypoalbuminaemia
10%
Fatigue
10%
Hypomagnesaemia
10%
Hypoxia
10%
Alanine aminotransferase increased
10%
Pain in extremity
10%
Upper respiratory tract infection
10%
Constipation
9%
Erythema
9%
Myalgia
9%
Oropharyngeal pain
9%
Petechiae
9%
Face oedema
9%
Back pain
9%
Hypotension
7%
Pain
7%
Insomnia
7%
Oedema peripheral
7%
Dry skin
7%
Rhinitis
7%
Thrombocytopenia
7%
Immunoglobulins decreased
7%
Lymphocyte count decreased
6%
Nasal congestion
6%
Blood fibrinogen decreased
6%
Haematuria
6%
Seizure
6%
Allergy to immunoglobulin therapy
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%
Dyskinesia
1%
Haemophagocytic lymphohistiocytosis
1%
Facial paralysis
1%
Somnolence
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
CASSIOPEIA 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
454 Previous Clinical Trials
237,820 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,234 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for me to join this clinical trial?
"To be considered for enrollment, individuals should have b-cell acute lymphoblastic leukemia and between 1 year old to 25 years. 140 potential candidates are needed in total."
Answered by AI
How many facilities are offering this clinical trial?
"This medical trial is being hosted at 53 different sites across the USA; including Children s Mercy Hospital in Kansas City, Mattel Childrens Hospital UCLA in Los Angeles, and Childrens Hospital Los Angeles SC CTL019 in Birmingham."
Answered by AI
Is this clinical trial pioneering in its approach to treatment?
"CTL019's progression through the drug trial process began in 2015, when Novartis Pharmaceuticals sponsored its first study. This initial clinical trial involved 115 patients and ultimately resulted in Phase 2 approval for CTL019. At present, there are 16 trials taking place across 114 cities and 22 countries around the world."
Answered by AI
Could you provide information on the background research that has been conducted concerning CTL019?
"Research on CTL019 first began in 2015 at Novartis Investigative Site, with 11 trials having been concluded since. As of now, 16 active experiments are taking place around the world; many based out of Kansas City, Missouri."
Answered by AI
How many participants have joined in this clinical trial thus far?
"Truly, the data noted on clinicaltrials.gov details that this scientific trial is actively searching for volunteers; it was posted in January 28th 2019 and most recently updated in October 31st 2022. The study requires recruiting 140 people from 53 distinct locations."
Answered by AI
Are there any opportunities to join this clinical exploration at the present moment?
"Data hosted on clinicaltrials.gov indicates that this medical study is recruiting volunteers, with the original post date being January 28th 2019 and the most recent edition having occurred October 31st 2022."
Answered by AI
Is this research endeavor open to participants aged 25 and over?
"According to the requirements for enrollment, participants must be between 1 and 25 years old. There are 472 clinical trials that accommodate minors and 1200 studies open to those over 65."
Answered by AI
What potential effects have been observed with utilization of CTL019?
"Based on the information at hand, CTL019 was rated a 2 for safety as it is still in its Phase 2 trial period and has not yet demonstrated efficacy."
Answered by AI
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