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Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

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ClinicalTrials.gov Identifier: NCT03483103
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Juno Therapeutics, Inc.

Brief Summary:
This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Lymphoma, Nonhodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Biological: lisocabtagene maraleucel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Lisocabtagene maraleucel at a dose of 100×10^6 CAR+ T cells (50×10^6 CD8+ CAR+ T cells and 50×10^6 CD4+ CAR+ T cells), will be given IV in a single-dose schedule on Day 1 (between 2 and 7 days following the completion of lymphodepleting chemotherapy).
Biological: lisocabtagene maraleucel
lisocabtagene maraleucel
Other Names:
  • JCAR017
  • liso-cel




Primary Outcome Measures :
  1. Antitumor activity [ Time Frame: Through Month 24 ]
    Overall response rate (complete response + partial response) based on "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification"


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 90 days ]
    Proportion of subjects experiencing adverse events

  2. Laboratory abnormalities [ Time Frame: 90 days ]
    Proportion of subjects experiencing laboratory abnormalities

  3. Antitumor activity [ Time Frame: Through Month 24 ]
    Complete response rate based on "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification"

  4. Antitumor activity [ Time Frame: Through Month 24 ]
    Duration of response

  5. Maximum concentration (Cmax) of lisocabtagene maraleucel in blood [ Time Frame: Through Month 24 ]
    Maximum concentration of lisocabtagene maraleucel in blood

  6. Time of the maximum concentration (Tmax) of lisocabtagene maraleucel in blood [ Time Frame: Through Month 24 ]
    Time of the maximum concentration of lisocabtagene maraleucel in blood

  7. Area under the curve of (AUC) lisocabtagene maraleucel concentration in blood [ Time Frame: Through Month 24 ]
    Area under the curve of lisocabtagene maraleucel in blood

  8. Progression-free survival [ Time Frame: Through Month 24 ]
    Progression-free survival

  9. Event-free survival [ Time Frame: Through Month 24 ]
    Event-free survival

  10. Overall survival [ Time Frame: Through Month 24 ]
    Overall survival

  11. Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 is a validated quality of life measure applicable to subjects with any cancer diagnosis. It is composed of 30 items that address general physical symptoms, physical functioning, fatigue and malaise, and social and emotional functioning. Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher scores on symptom scales indicating worse symptoms. A 10 point change in the scoring is considered to be a meaningful change in HRQoL.

  12. Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    The EuroQol-5D (EQ-5D) is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The VAS rating scale is a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

  13. Health-related quality of life and health economics and outcomes research [ Time Frame: Through month 24 ]
    The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) consists of the FACT-General scale and a 15-item lymphoma-specific additional concerns subscale (LYM). This scale addresses symptoms and functional limitations that are important to lymphoma patients. Only the LYM subscale will be administered in this study. The LYM items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale.

  14. Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    Numbers of intensive care unit inpatient days and non-ICU inpatient days and reasons for hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]), and follicular lymphoma Grade 3B per WHO 2016 classification
  • Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
  • Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
  • Positron emission tomography (PET)-positive disease
  • Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
  • ECOG performance status of 0, or 1, or 2
  • Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)

Exclusion Criteria:

  • Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
  • History of another primary malignancy that has not been in remission for at least 2 years.
  • Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
  • Active hepatitis B or hepatitis C infection at the time of screening
  • History of or active human immunodeficiency virus (HIV) infection at the time of screening
  • Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
  • History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
  • History or presence of clinically relevant CNS pathology
  • Nursing women
  • Subject does not meet protocol-specified washout periods for prior treatments
  • Prior hematopoietic stem cell transplant
  • Tumor invasion of venous or arterial vessels
  • Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 3 months of leukapheresis and/or DVT or PE that requires ongoing therapeutic levels of anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483103


Contacts
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Contact: Juno Medical Information 866-599-JUNO (5866) medicalinformation@junotherapeutics.com

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Noelle Michael, RN       Noelle.Michael@bannerhealth.com   
Principal Investigator: Javier L Munoz, MD, MS, FACP         
United States, California
Sutter Medical Center Recruiting
Sacramento, California, United States, 95816
Contact: Melissa Sharkey    916-454-6962    sharkeym@sutterhealth.org   
Principal Investigator: Michael Carroll, MD         
United States, Georgia
The Blood and Marrow Transplant Group of Georgia Recruiting
Atlanta, Georgia, United States, 30342
Contact: Stacey Brown    404-851-8238    stacey.brown@northside.com   
Principal Investigator: Scott Solomon, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Lori Ackatz    312-695-3527    lori.ackatz@northwestern.edu   
Principal Investigator: Leo Gordon, MD         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Gerhard Hildebrandt, MD    859-257-3379      
Principal Investigator: Gerhard Hildebrandt, MD         
Norton Cancer Institute - Brownsboro Recruiting
Louisville, Kentucky, United States, 40241
Contact: Dana Haycraft    502-899-3366 ext 19287    dana.haycraft@nortonhealthcare.org   
Principal Investigator: Don Stevens, MD         
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Lesley Donoho-Cohen, RN    410-614-0482    Ldonoho1@jhmi.edu   
Principal Investigator: Nina Wagner-Johnston, MD         
United States, New Jersey
Regional Cancer Care Associates Recruiting
East Brunswick, New Jersey, United States, 08816
Contact: Percy Yeung    732-390-7750 ext 3378    pyeung@regionalcancercare.org   
Principal Investigator: Edward Licitra, MD, PhD         
United States, New York
New York Oncology Hematology - Albany Cancer Center Recruiting
Albany, New York, United States, 12208
Contact: Susan Brignull    518-262-2768    susan.brignull@usoncology.com   
Principal Investigator: Courtney Bellomo, MD         
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Sally Ware    980-442-2030    sally.ware@atriumhealth.org   
Principal Investigator: Nilanjan Ghosh, MD, PhD         
United States, Ohio
Oncology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Doug Hart    513-751-2273 ext 42401    douglas.hart@usoncology.com   
Principal Investigator: James Essell, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Larisa Lundgren    503-215-2614    Larisa.Lundgren@providence.org   
Principal Investigator: John Godwin, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center, Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Linda Fukas, RN    412-623-6037    fukaslj@upmc.edu   
Contact: Bridget Sweterlitsch       sweterlitschbm@ph.upmc.edu   
Principal Investigator: Alison Sehgal, MD         
United States, South Carolina
Greenville Health System - Cancer Institute - Faris Road Recruiting
Greenville, South Carolina, United States, 29605
Contact: Sara Roman    864-242-2720    sara.roman@prismahealth.org   
Principal Investigator: Suzanne Fanning, DO         
United States, Utah
Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Shelby Kirby    801-408-2058    shelby.kirby@imail.org   
Principal Investigator: Daanish Hoda, MD         
United States, Washington
Northwest Medical Specialties Recruiting
Tacoma, Washington, United States, 98405
Contact: Jessica Reynolds    253-200-3147    jreynolds@nwmsonline.com   
Principal Investigator: Francis Senecal, MD         
United States, Wisconsin
Medical College of Wisconsin, Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Kaylee Meisinger    414-805-8926    kmeisinger@mcw.edu   
Principal Investigator: Sayed Mehdi Hamadani, MD         
Sponsors and Collaborators
Juno Therapeutics, Inc.
Celgene Corporation
Investigators
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Study Director: Nick Trede, MD, PhD Juno Therapeutics, Inc.

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Responsible Party: Juno Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03483103     History of Changes
Other Study ID Numbers: 017006
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juno Therapeutics, Inc.:
JCAR017
lisocabtagene maraleucel
NHL
chimeric antigen receptor
CAR
CAR T cell
autologous T cell therapy
immunotherapy
cell therapy
liso-cel
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases