Trial Search Results

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

This study involves the infusion of participants' own blood cells that have been genetically modified to target and destroy leukemia cells, called "chimeric antigen receptor T cells". This product is calledtisagenlecleucel. In a sample of 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 (a few months after the start of their leukemia treatment), the primary objective for this study is to evaluate the efficacy of tisagenlecleucel therapy, as measured by the 5 year disease-free survival (DFS).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Collaborator: Children's Oncology Group

Stanford Investigator(s):

Intervention(s):

  • Biological: CTL019

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   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:

      - no or mild dyspnea (≤ Grade 1)

      - 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

   6. 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.

Exclusion Criteria:

   1. M3 marrow at the completion of 1st line induction therapy

   2. M2 or M3 marrow or persistent extramedullary disease at the completion of first-line
   consolidation therapy or evidence of disease progression in the peripheral blood or
   new extramedullary disease prior to enrollment. Patients with previous CNS disease are
   eligible if there is no active CNS involvement of leukemia at the time of screening.

   3. Philadelphia chromosome positive ALL

   4. Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence
   of a hypodiploid clone

   5. Prior tyrosine kinase inhibitor therapy

   6. Subjects with concomitant genetic syndromes associated with bone marrow failure
   states: such as subjects with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or
   any other known bone marrow failure syndrome. Subjects with Down syndrome will not be
   excluded.

   7. Subjects with Burkitt's lymphoma/leukemia (i.e. subjects with mature B-ALL, leukemia
   with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3
   morphology and /or a MYC translocation)

   8. Has had treatment with any prior anti-CD19 therapy 9. Treatment with any prior gene or
   engineered T cell therapy

Other protocol-defined inclusion/exclusion may apply.

Ages Eligible for Study

1 Year - 25 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michelle Fujimoto
650-504-5432
Not Recruiting