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CAR T-cell Therapy
Second Infusion of Tisagenlecleucel for Acute Lymphoblastic Leukemia
Phase 2
Recruiting
Led By Kevin Curran, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 1 year
Awards & highlights
Study Summary
This trial is to see if an early second infusion of tisagenlecleucel can keep B-cell aplasia at bay for longer. They will also assess safety and efficacy.
Who is the study for?
This trial is for children and young adults under 26 with B-cell Acute Lymphoblastic Leukemia who've had a previous tisagenlecleucel infusion. They must have normal organ function, no severe ongoing side effects from the first treatment, and not be pregnant or breastfeeding. Participants need to agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests whether an early second dose of tisagenlecleucel can maintain cancer remission at six months post-first infusion in patients with B-ALL. It also evaluates the safety and effectiveness of this reinfusion strategy.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever, difficulty breathing, rapid heartbeat, feeling weak or tired; neurological issues like confusion or seizures; liver problems; low blood cell counts increasing infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
decrease the loss of peripheral BCA rate
Secondary outcome measures
number and percentage of toxicities with early reinfusion of CAR T cells
Side effects data
From 2022 Phase 2 trial • 115 Patients • NCT0244524848%
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%
Fatigue
24%
Hypotension
23%
Hypokalaemia
21%
Headache
18%
Neutropenia
17%
Constipation
17%
Hypomagnesaemia
17%
Hypophosphataemia
17%
Cough
15%
Oedema peripheral
14%
Arthralgia
14%
Dyspnoea
13%
Decreased appetite
13%
Thrombocytopenia
13%
Upper respiratory tract infection
12%
Chills
12%
Dizziness
12%
Weight decreased
10%
Febrile neutropenia
10%
Tachycardia
10%
Blood creatinine increased
10%
Anxiety
9%
Urinary tract infection
9%
Pain in extremity
9%
Hypogammaglobulinaemia
8%
Abdominal pain
8%
Hyponatraemia
8%
Vomiting
8%
Influenza like illness
8%
Nasopharyngitis
8%
Pneumonia
7%
Insomnia
7%
Asthenia
7%
Sinusitis
7%
Confusional state
7%
Hypoxia
6%
Back pain
6%
Stomatitis
6%
Influenza
6%
Blood immunoglobulin G decreased
6%
Lymphocyte count decreased
6%
Myalgia
5%
Dry mouth
5%
Pain
5%
Hypocalcaemia
5%
Acute kidney injury
5%
Pleural effusion
5%
Rash
5%
Oropharyngeal pain
5%
Night sweats
3%
Myelodysplastic syndrome
3%
Multiple organ dysfunction syndrome
3%
Clostridium difficile infection
3%
Sepsis
3%
Encephalopathy
3%
Prostate cancer
3%
Pancytopenia
2%
Bone marrow failure
2%
Gastrointestinal haemorrhage
2%
Infection
2%
Respiratory tract infection
2%
Staphylococcal infection
2%
Dehydration
2%
Respiratory failure
2%
Pneumocystis jirovecii pneumonia
2%
Pulmonary embolism
1%
Acute myeloid leukaemia
1%
Haemophagocytic lymphohistiocytosis
1%
Syncope
1%
C-reactive protein increased
1%
Hepatic failure
1%
Bronchopulmonary aspergillosis
1%
Urosepsis
1%
Polyarthritis
1%
Pulmonary haemorrhage
1%
Lymphadenopathy
1%
Atrial fibrillation
1%
Cardiac arrest
1%
Cardiac failure congestive
1%
Cardio-respiratory arrest
1%
Cardiopulmonary failure
1%
Vertigo
1%
Anal fissure
1%
Duodenal ulcer haemorrhage
1%
Haematemesis
1%
Large intestinal obstruction
1%
Melaena
1%
Pancreatitis acute
1%
Face oedema
1%
Cholecystitis acute
1%
Atypical pneumonia
1%
Bronchitis
1%
Candida infection
1%
Cerebral toxoplasmosis
1%
Corynebacterium infection
1%
Escherichia infection
1%
Lower respiratory tract infection
1%
Systemic infection
1%
Vaginal infection
1%
Blood bilirubin increased
1%
Liver function test increased
1%
Hypercalcaemia
1%
Tumour lysis syndrome
1%
Acute polyneuropathy
1%
Cerebral haemorrhage
1%
Demyelinating polyneuropathy
1%
Ischaemic cerebral infarction
1%
Metabolic encephalopathy
1%
Somnolence
1%
Status epilepticus
1%
Mental status changes
1%
Chronic kidney disease
1%
Urinary tract obstruction
1%
Allergic bronchitis
1%
Asphyxia
1%
Pneumonitis
1%
Deep vein thrombosis
1%
Neuroendocrine carcinoma
1%
Upper limb fracture
1%
Refractory cytopenia with multilineage dysplasia
1%
Pharyngeal haemorrhage
1%
Myopathy
1%
Tumour haemorrhage
1%
Pneumonia aspiration
1%
Pseudomonas infection
1%
Tumour associated fever
1%
Invasive ductal breast carcinoma
1%
Malignant melanoma
1%
Cystitis haemorrhagic
1%
Infusion related reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisagenlecleucel - All Patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: TisagenlecleucelExperimental Treatment1 Intervention
Patients will receive reinfusion of tisagenlecleucel on day +30-60 after their initial infusion if meeting eligibility criteria. Tisagenlecleucel is an autologous cellular immunotherapy product that is comprised of CD3+T cells that have undergone ex vivo T cell activation, gene modification, expansion, and formulation in infusible cryomedia.
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 PharmaceuticalsIndustry Sponsor
2,865 Previous Clinical Trials
4,199,252 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,938 Previous Clinical Trials
588,336 Total Patients Enrolled
Kevin Curran, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a sexually active male unwilling to use a condom.It has been over 60 days since my first tisagenlecleucel infusion.My recent tests show no cancer signs in my bone marrow.My CAR T cell therapy is considered out of specification but is not expected to affect its safety or effectiveness.I have recovered from the major side effects of my initial tisagenlecleucel treatment.My organs are functioning well enough for treatment.I am physically active and can do most of my daily activities.I do not have any serious ongoing infections.I have relapsed or refractory B-ALL and can get more doses of tisagenlecleucel.I am experiencing severe side effects from my first CAR T cell treatment.I am younger than 26 years old when my first tisagenlecleucel order was placed.I had special chemotherapy before my first tisagenlecleucel dose.I had B-cell Acute Lymphoblastic Leukemia before receiving tisagenlecleucel.I have a serious illness that is not under control and causes symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Tisagenlecleucel
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 this clinical trial only open to people who are 18 years old or younger?
"According to the eligibility requirements for this trial, participants must be aged between 1 day and 25 years old."
Answered by AI
How many subjects are enrolled in this trial?
"Yes, the information on clinicaltrials.gov indicates that this study is presently seeking participants. The study was originally posted on 7/12/2022 and was most recently updated on 7/13/2022. The clinical trial is looking for 33 participants across 1 sites."
Answered by AI
Who does this study's criteria permit to enroll?
"The requirements to participate in this research are having b-lymphocytes and being between 1 day old to 25 years old. So far, 33 people have met the criteria."
Answered by AI
Are patients currently being screened for this study?
"The clinical trial is currently recruiting patients, with the initial posting on 7/12/2022 and the most recent update on 7/13/2022."
Answered by AI
Has the Tisagenlecleucel gone through regulatory approval by the FDA?
"Tisagenlecleucel is a Phase 2 medication, so while there is data suggesting it is safe, Power cannot confirm that it is effective."
Answered by AI
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