Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients (NCT02435849) | Clinical Trial Compass
CompletedPhase 2
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
United States, Australia, Austria80 participantsStarted 2015-04-08
Plain-language summary
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Relapsed or refractory pediatric B-cell ALL
. Adequate organ function
. For relapsed patients, documentation of CD19 tumor expression within 3 months of study entry.
. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
. Life expectancy \> 12 weeks.
. Karnofsky (age ≥16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening
. Signed written informed consent and assent forms
. Must meet the institutional criteria to undergo leukapheresis or have an acceptable, store leukapheresis product
Exclusion criteria
. Isolated extra-medullary disease relapse
. Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Overall Remission Rate (ORR) as Determined by Independent Review Committee (IRC) Assessment.
Timeframe: during the 3 months after tisagenlecleucel administration
. Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation)
. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
. Treatment with any prior gene therapy product
. Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
. Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
. Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening