Acute Lymphoblastic Leukemia (CASSIOPEIA)

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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.

Overview

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

Study Goal

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.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

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

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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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.

Definitions:
de novo - (newly diagnosed), ICF - informed consent form, HR - high-risk

Last Updated: July 19, 2019

8/19 M-GON-1216061