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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 : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Juno Therapeutics, a Subsidiary of Celgene

Tracking Information
First Submitted Date  ICMJE March 23, 2018
First Posted Date  ICMJE March 30, 2018
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE July 26, 2018
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
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"
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Adverse events [ Time Frame: 90 days ]
    Proportion of subjects experiencing adverse events
  • Laboratory abnormalities [ Time Frame: 90 days ]
    Proportion of subjects experiencing laboratory abnormalities
  • 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"
  • Antitumor activity [ Time Frame: Through Month 24 ]
    Duration of response
  • Maximum concentration (Cmax) of lisocabtagene maraleucel in blood [ Time Frame: Through Month 24 ]
    Maximum concentration of lisocabtagene maraleucel in blood
  • 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
  • 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
  • Progression-free survival [ Time Frame: Through Month 24 ]
    Progression-free survival
  • Event-free survival [ Time Frame: Through Month 24 ]
    Event-free survival
  • Overall survival [ Time Frame: Through Month 24 ]
    Overall survival
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • Adverse events [ Time Frame: 90 days ]
    Proportion of subjects experiencing adverse events
  • Laboratory abnormalities [ Time Frame: 90 days ]
    Proportion of subjects experiencing laboratory abnormalities
  • 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"
  • Antitumor activity [ Time Frame: Through Month 24 ]
    Duration of response
  • Pharmacokinetics [ Time Frame: Through Month 24 ]
    Maximum concentration of lisocabtagene maraleucel in blood
  • Pharmacokinetics [ Time Frame: Through Month 24 ]
    Time of the maximum concentration of lisocabtagene maraleucel in blood
  • Pharmacokinetics [ Time Frame: Through Month 24 ]
    Area under the curve of lisocabtagene maraleucel in blood
  • Progression-free survival [ Time Frame: Through Month 24 ]
    Progression-free survival
  • Overall survival [ Time Frame: Through Month 24 ]
    Overall survival
  • Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    EORTC QLQ-C30
  • Health-related quality of life and health economics and outcomes research [ Time Frame: Through Month 24 ]
    EuroQol instrument EQ-5D-5L
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
Official Title  ICMJE A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Nonhodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
Intervention  ICMJE Biological: lisocabtagene maraleucel
lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection
Other Names:
  • JCAR017
  • liso-cel
Study Arms  ICMJE 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).
Intervention: Biological: lisocabtagene maraleucel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • Subjects must agree to use appropriate contraception
  • Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy

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
  • Pregnant or nursing women
  • Subject does not meet protocol-specified washout periods for prior treatments
  • Prior hematopoietic stem cell transplant
  • Progressive vascular tumor invasion, thrombosis, or embolism
  • Venous thrombosis or embolism not managed on stable regimen of anticoagulation
  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03483103
Other Study ID Numbers  ICMJE 017006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juno Therapeutics, a Subsidiary of Celgene
Study Sponsor  ICMJE Juno Therapeutics, a Subsidiary of Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nick Trede, MD, PhD Juno Therapeutics, Inc.
PRS Account Juno Therapeutics, a Subsidiary of Celgene
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP