Acute Lymphoblastic Leukemia (CASSIOPEIA)
A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy.
|This Study Is Recruiting: Phase II||Actual Start Date: [June 24, 2019]||Estimated Completion Date: [April 2027]||Novartis Reference Number: CCTL019G2201J|
|Condition: Acute Lymphoblastic Leukemia (ALL)||Interventions: Tisagenlecleucel||Estimated Enrollment: [160 participants]||ClinicalTrials.gov Identifier: NCT03876769|
|This Study Is Recruiting: Phase II||Actual Start Date: [June 24, 2019]|
|Estimated Completion Date: [April 2027]||Novartis Reference Number: CCTL019G2201J|
|Condition: Acute Lymphoblastic Leukemia (ALL)||Interventions: Tisagenlecleucel|
|Estimated Enrollment: [160 participants]||ClinicalTrials.gov Identifier: NCT03876769|
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After tisagenlecleucel infusion, efficacy will be assessed at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Safety will be assessed throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up for lentiviral vector safety will continue under a separate protocol per health authority guidelines.
Participants may be eligible to participate if they:
- Are 1 to 25 years of age
- Have CD19-expressing (in peripheral blood or bone marrow by flow cytometry) B-cell ALL
- Have de novo National Cancer Institute-defined high-risk B-ALL who received first-line treatment
- Have minimal residual disease (MRD) ≥ 0.01% at the end of consolidation therapy
- Meet other eligibility criteria
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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.
de novo - (newly diagnosed), ICF - informed consent form, HR - high-risk
Last Updated: July 19, 2019