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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

Official Title

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Keywords

Diffuse Large B-cell Lymphoma (DLBCL) Diffuse large B-cell lymphoma, DLBCL, Relapsed/refractory, CTL019 CART19 CART CAR T cells Chimeric antigen receptor

Eligibility

You can join if…

Open to people ages 18 years and up

  • Written informed consent must be obtained prior to any screening procedures
  • Histologically confirmed DLBCL at last relapse(by central pathology review before enrolment.

    .- Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not consenting to ASCT

  • Measurable disease at time of enrollment
  • Life expectancy ≥12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening
  • Adequate organ function:
  • Renal function defined as:
  • A serum creatinine of ≤1.5 x Upper Limit of Normal ULN OR
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m2
  • Liver function defined as:
  • Alanine Aminotransferase (ALT) ≤ 5 times the Upper Limit of Normal (ULN)for age
  • Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation> 91% on room air
  • Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) ≥ 45%confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)
  • Adequate bone marrow reserve without transfusions defined as:
  • Absolute neutrophil count (ANC)> 1.000/mm3
  • Absolute lymphocyte count (ALC) ≥ 300/mm3
  • Platelets ≥ 50.000//mm3
  • Hemoglobin> 8.0 g/dl
  • Must have an apheresis product of non-mobilized cells accepted for manufacturing
  • Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for at least 12 months following CTL019 infusion and until CAR T cells are no longer present by PCR on two consecutive tests

You CAN'T join if...

  • Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
  • Treatment with any prior gene therapy product
  • Active Central Nervous System (CNS) involvement by malignancy
  • Prior allogeneic HSCT
  • Eligible for and consenting to ASCT
  • Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
  • Investigational medicinal product within the last 30 days prior to screening
  • The following medications are excluded:
  • Steroids: Therapeutic doses of steroids must be stopped> 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 6 - 12 mg/m2/day hydrocortisone or equivalent
  • Immunosuppression: Any immunosuppressive medication must be stopped ≥ 4 weeks prior to enrollment
  • Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of infusion
  • Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respected antibody, whichever is longer
  • CNS disease prophylaxis must be stopped> 1 week prior to CTL019 infusion (e.g.intrathecal methotrexate)
  • Prior radiation therapy within 2 weeks of infusion
  • Active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive )
  • HIV positive patients
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 6 months prior to screening
  • Previous or concurrent malignancy with the following exceptions:
  • Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
  • In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study
  • A primary malignancy which has been completely resected and in complete remission for ≥ 5 years
  • Investigational medicinal product within the last 30 days prior to screening
  • Pregnant or nursing (lactating) women
  • Intolerance to the excipients of the CTL019 cell product
  • Cardiac arrhythmia not controlled with medical management
  • Patients on oral anticoagulation therapy
  • Prior treatment with any adoptive T cell therapy
  • Patients with active neurological auto immune or inflammatory disorders(e.g. Guillain Barre Syndrome, Amyptrophic Lateral Sclerosis)

    Other protocol-related inclusion/exclusion may apply.

Locations

  • Mayo Clinic - Arizona Mayo Clinic Building in progress, not accepting new patients
    Phoenix, Arizona, 85054, United States
  • Oregon Health & Science University in progress, not accepting new patients
    Portland, Oregon, 97239, United States
  • University of Kansas Cancer Center in progress, not accepting new patients
    Westwood, Kansas, 66205, United States
  • MD Anderson Cancer Center SC in progress, not accepting new patients
    Houston, Texas, 77030, United States
  • University of Minnesota SC C2201 in progress, not accepting new patients
    Minneapolis, Minnesota, 55455, United States
  • University of Chicago Medical Center, Hematology & Oncology in progress, not accepting new patients
    Chicago, Illinois, 60637, United States
  • University of Michigan Health System in progress, not accepting new patients
    Ann Arbor, Michigan, 48109, United States
  • The Ohio State University James Cancer Hospital & in progress, not accepting new patients
    Columbus, Ohio, 43210, United States
  • Emory University School of Medicine/Winship Cancer Institute in progress, not accepting new patients
    Atlanta, Georgia, 30322, United States
  • Novartis Investigative Site in progress, not accepting new patients
    Hamilton, Ontario, L8V 5C2, Canada
  • Duke Unversity Medical Center in progress, not accepting new patients
    Durham, North Carolina, 27705, United States
  • The Sidney Kimmel Cancer Center at Johns Hopkins Hospital SC-2 in progress, not accepting new patients
    Baltimore, Maryland, 21287-0013, United States
  • University of Pennsylvania in progress, not accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Novartis Investigative Site in progress, not accepting new patients
    Montreal, Quebec, H1T 2M4, Canada
  • Weill Cornell Medical College in progress, not accepting new patients
    New York, New York, 10021, United States
  • Novartis Investigative Site accepting new patients
    Oslo, NO-0424, Norway
  • Novartis Investigative Site accepting new patients
    Sapporo-city, Hokkaido, 060-8648, Japan
  • Novartis Investigative Site accepting new patients
    Chuo-ku, Tokyo, 104-0045, Japan
  • Novartis Investigative Site accepting new patients
    Amsterdam, 1105 AZ, Netherlands
  • Novartis Investigative Site accepting new patients
    Pierre Benite, 69495, France
  • Novartis Investigative Site accepting new patients
    Koeln, Nordrhein-Westfalen, 50937, Germany
  • Novartis Investigative Site accepting new patients
    Würzburg, 97080, Germany
  • Novartis Investigative Site accepting new patients
    Vienna, A-1090, Austria
  • Novartis Investigative Site accepting new patients
    Milano, MI, 20133, Italy
  • Novartis Investigative Site accepting new patients
    Camperdown, VIC 2050, Australia
  • Novartis Investigative Site accepting new patients
    Melbourne, VIC 3002, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02445248
Phase
Phase 2
Lead Scientist
Charalambos Andreadis
Study Type
Interventional
Last Updated
April 1, 2017