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Second Infusion of Tisagenlecleucel for Acute Lymphoblastic Leukemia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 34 Patients • NCT03610724Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Tisagenlecleucel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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