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Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
1 - 25 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03876769
Protocol IDs
CCTL019G2201J (primary)
NCI-2019-02353
Study Sponsor
Novartis Pharmaceuticals Corporation

Summary

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, patient will have assessments performed more frequently in the
first month and then 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. Efficacy and safety will be assessed
at study visits and as clinically indicated 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 safety will continue under a separate protocol per health authority
guidelines.

Eligibility

  1. CD19 expressing B-cell Acute Lymphoblastic Leukemia
  2. De novo NCI HR B-ALL who received first-line treatment and are MRD = 0.01% at EOC. EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis.
  3. Age 1 to 25 years at the time of screening
  4. Lansky (age < 16 years) or Karnofsky (age = 16 years) performance status = 60%
  5. Adequate organ function during the screening period: A. Renal function based on age/gender B. ALT = 5 times ULN for age C. AST = 5 times ULN for age D. Total bilirubin < 2 mg/dL (for Gilbert's Syndrome subjects total bilirubin < 4 mg/dL) E. Adequate pulmonary function defined as:
  6. no or mild dyspnea (= Grade 1)
  7. oxygen saturation of > 90% on room air F. Adequate cardiac function defined as LVSF = 28% confirmed by echocardiogram or LVEF = 45% confirmed by echocardiogram or MUGA within 6 weeks of screening
  8. Prior induction and consolidation chemotherapy allowed: 1st line subjects: = 3 blocks of standard chemotherapy for first-line B-ALL, defined as 4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or Phase 1b, and interim maintenance with high-dose methotrexate.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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