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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
Patients age < 26 years at time of first tisagenlecleucel order placement
Recovered from severe toxicities following initial dose of tisagenlecleucel
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am younger than 26 years old when my first tisagenlecleucel order was placed.
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I have recovered from the major side effects of my initial tisagenlecleucel treatment.
Select...
I have relapsed or refractory B-ALL and can get more doses of tisagenlecleucel.
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I had B-cell Acute Lymphoblastic Leukemia before receiving tisagenlecleucel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 2023 Phase 2 trial • 34 Patients • NCT03610724
48%
Cytokine release syndrome
42%
Pyrexia
39%
Vomiting
33%
Anaemia
30%
Neutrophil count decreased
27%
Platelet count decreased
27%
Nausea
24%
White blood cell count decreased
24%
Headache
21%
Neutropenia
18%
Abdominal pain
15%
Stomatitis
15%
Fatigue
15%
Cough
15%
Leukopenia
15%
Blood creatinine increased
15%
Hypokalaemia
15%
Alanine aminotransferase increased
15%
Decreased appetite
12%
Chills
12%
Epistaxis
12%
Thrombocytopenia
12%
Tachycardia
12%
Hypomagnesaemia
9%
Pleural effusion
9%
Sinus tachycardia
9%
Diarrhoea
9%
Catheter site pain
9%
Blood lactate dehydrogenase increased
9%
Hyperphosphataemia
9%
Paraesthesia
9%
Pruritus
9%
Weight decreased
9%
Hypogammaglobulinaemia
9%
Hypertension
9%
Lymphocyte count decreased
9%
Constipation
9%
Infusion related reaction
6%
Peripheral sensorimotor neuropathy
6%
Seizure
6%
Acute kidney injury
6%
Febrile neutropenia
6%
Lymphopenia
6%
Abdominal pain upper
6%
Small intestinal obstruction
6%
Cholelithiasis
6%
Aspartate aminotransferase increased
6%
Blood bilirubin increased
6%
Serum ferritin increased
6%
Hyponatraemia
6%
Hypophosphataemia
6%
Arthralgia
6%
Neuralgia
6%
Neuropathy peripheral
6%
Depression
6%
Alopecia
6%
Dry skin
6%
Rash
6%
Haematoma
6%
Hypotension
6%
Neck pain
6%
Vision blurred
6%
Gastrooesophageal reflux disease
6%
Oedema peripheral
6%
Pain in extremity
6%
Anxiety
6%
Bone marrow failure
6%
Drug hypersensitivity
6%
Dizziness
6%
Depressed level of consciousness
6%
Insomnia
6%
Pain
6%
Myelitis
6%
SARS-CoV-2 test positive
6%
Tachypnoea
6%
Lower gastrointestinal haemorrhage
6%
Generalised oedema
6%
Coagulopathy
3%
Cardiac arrest
3%
Large intestinal obstruction
3%
Dental caries
3%
Proctitis
3%
Pseudomonas infection
3%
Sepsis
3%
Vascular device infection
3%
Ejection fraction decreased
3%
Aphasia
3%
Hemiparesis
3%
Motor dysfunction
3%
Pneumothorax
3%
Disease progression
3%
Pancreatitis
3%
Chest pain
3%
Condition aggravated
3%
Memory impairment
3%
Respiratory failure
3%
Back pain
3%
Disturbance in attention
3%
Haemophagocytic lymphohistiocytosis
3%
Urinary tract infection
3%
Respiratory distress
3%
Aspergillus infection
3%
Candida infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisagenlecleucel - Post-infusion
Tisagenlecleucel - Pre-infusion Deaths

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
2,852 Previous Clinical Trials
4,197,712 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,345 Total Patients Enrolled
Kevin Curran, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
101 Total Patients Enrolled

Media Library

Tisagenlecleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05460533 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Tisagenlecleucel
Acute Lymphoblastic Leukemia Clinical Trial 2023: Tisagenlecleucel Highlights & Side Effects. Trial Name: NCT05460533 — Phase 2
Tisagenlecleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05460533 — Phase 2

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
~19 spots leftby Jul 2026