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AzTrials

Lymphoma, Non-HodgkinPhase 2NCT03483103

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

A Phase 2 study testing lisocabtagene maraleucel in people with Lymphoma, Non-Hodgkin and Lymphoma, Nonhodgkin, run by Juno Therapeutics, a Subsidiary of Celgene at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lisocabtagene maraleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
59 sitesUnited States
Study dates
27 Jul 2018to 1 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • New York Oncology Hematology - Albany Cancer Center

    Albany, New York, 12208

  • New York Oncology Hematology P.C.

    Albany, New York, 12208

  • Local Institution - 0019

    Atlanta, Georgia, 30342

  • The Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, 30342

  • UNC School of Medicine

    Atlanta, Georgia, 30342

  • Johns Hopkins Oncology Center Bunting Blaustein Building

    Baltimore, Maryland, 21231

  • Local Institution - 0009

    Baltimore, Maryland, 21231

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Local Institution - 0021

    Charlotte, North Carolina, 28204

  • Local Institution - 0003

    Chicago, Illinois, 60611

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Local Institution - 0016

    Chicago, Illinois, 60637-1470

  • University of Chicago

    Chicago, Illinois, 60637-1470

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Local Institution - 0039

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care

    Cincinnati, Ohio, 45236

  • Local Institution - 0083

    Dallas, Texas, 75390-7208

  • UNC School of Medicine

    Dallas, Texas, 75390

  • Local Institution - 0052

    East Brunswick, New Jersey, 08816

  • Regional Cancer Care Associates

    East Brunswick, New Jersey, 08816

  • UNC School of Medicine

    East Brunswick, New Jersey, 08816

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Local Institution - 0043

    Gilbert, Arizona, 85234

  • Greenville Health System - Cancer Institute - Faris Road

    Greenville, South Carolina, 29605

  • Greenville Health System

    Greenville, South Carolina, 29615

  • Local Institution - 0037

    Greenville, South Carolina, 29615

  • Scripps Clinic

    La Jolla, California, 92037

  • Local Institution - 0046

    Lexington, Kentucky, 40536

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Kentucky

    Lexington, Kentucky, 40536

  • UNC School of Medicine

    Los Angeles, California, 90095

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Local Institution - 0064

    Louisville, Kentucky, 40241

  • Norton Cancer Institute - Brownsboro

    Louisville, Kentucky, 40241

  • UNC School of Medicine

    Louisville, Kentucky, 40241

  • Local Institution - 0055

    Milwaukee, Wisconsin, 53226

  • Medical College of Wisconsin, Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • UNC School of Medicine

    Milwaukee, Wisconsin, 53226

  • Local Institution - 0029

    Pittsburgh, Pennsylvania, 15232

  • University of Pittsburgh Medical Center Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0051

    Portland, Oregon, 97213

  • Providence Cancer Center/Earle A. Chiles Res. Inst.

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Local Institution - 0090

    Rochester, New York, 14642

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Sutter Hematology and Oncology

    Sacramento, California, 95816

  • Sutter Medical Center

    Sacramento, California, 95816

  • Intermountain Healthcare - LDS Hospital Blood and Marrow Transplant

    Salt Lake City, Utah, 84143

  • Intermountain Healthcare - LDS Hospital

    Salt Lake City, Utah, 84143

  • Local Institution - 0074

    Salt Lake City, Utah, 84143

  • Stanford Cancer Genetics Clinic

    Stanford, California, 94304

  • Local Institution - 0092

    Stanford, California, 94305

  • Stanford Cancer Center

    Stanford, California, 94305

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • UNC School of Medicine

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)

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.

Being tested
lisocabtagene maraleucel
Keywords
JCAR017, lisocabtagene maraleucel, NHL, chimeric antigen receptor, CAR, CAR T cell, autologous T cell therapy, immunotherapy, cell therapy, liso-cel
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lisocabtagene maraleucelBiological

    Also called JCAR017, liso-cel

    lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection

Study groups in NCT03483103
Study groupRoleWhat they receive
TreatmentExperimentalLisocabtagene 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).
Receives: Biological: lisocabtagene maraleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    Overall response rate is the percent of participants with a best overall response (BOR) of either complete response (CR) or partial reasons (PR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.

    CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.

    PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.

    PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

    Measured: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)

Secondary outcomes (36)

  1. Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)

    A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.

    Measured: From first dose to 90 days following first dose (up to approximately 90 days)

  2. Change From Baseline of Hematology Laboratory Results: Hemoglobin

    Change from baseline in Hematology laboratory analysis. Includes Hemoglobin. Baseline is the last observation collected prior to or on the date of product infusion.

    Measured: Baseline and Day 29

  3. Change From Baseline of Hematology Laboratory Results: Leukocytes, Lymphocytes, Neutrophils, Platelets

    Change from baseline in Hematology laboratory analysis. Includes Leukocytes, Lymphocytes, Neutrophils, and Platelets. Baseline is the last observation collected prior to or on the date of product infusion.

    Measured: Baseline and Day 29

  4. Change From Baseline of Chemistry Laboratory Results: Albumin

    Change from baseline in Chemistry laboratory analysis. Includes Albumin. Baseline is the last observation collected prior to or on the date of product infusion.

    Measured: Baseline and Day 29

  5. Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase

    Change from baseline in Chemistry laboratory analysis. Includes Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase. Baseline is the last observation collected prior to or on the date of product infusion.

    Measured: Baseline and Day 29

  6. Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate

    Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.

    Measured: Baseline and Day 29

  7. Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium

    Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.

    Measured: Baseline and Day 29

  8. Complete Response (CR) Rate

    Complete response rate (CRR) was defined as the percent of participants with a best overall response (BOR) of complete response (CR) based on the Independent Review Committee (IRC) assessment recorded from the time of JCAR017 treatment until disease progression, end of study, the start of another anticancer therapy or JCAR017 retreatment.

    CR = Score 1, 2, or 3 with or without a residual mass on the positron emission tomography 5-point scale (PET 5PS). A score of 3 in many patients indicates a good prognosis with standard treatment.

    PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

    Measured: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplant (up to approximately 24 months)

  9. Duration of Response (DOR)

    Duration of response (DOR) is defined as the time from first complete response(CR) or partial response (PR) to progressive disease (PD) or death, whichever occurred first.

    CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.

    PR = Score 4 or 5b with reduced uptake compared with baseline and residual mass(es) of any size.

    PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

    PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

    Measured: From first dose to up to approximately 24 months

  10. Duration of Response (DOR) in Participants With Complete Response (CR)

    DOR for participants with a best overall response of CR was defined as the time from documentation of first response (or CR) to progressive disease (PD) or death, whichever occurred first. The first documentation of CR/PR is the latest of all dates of required measurements to establish the response. The progression date is the earliest date of all assessments that led to a response assessment of PD.

    CR = Score 1, 2, or 3 on the positron emission tomography 5-point scale (PET 5PS). A score of 3 indicates a good prognosis with standard treatment.

    PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

    PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

    Measured: From first dose to up to approximately 24 months

  11. Progression-Free Survival (PFS)

    PFS is defined as the time from JCAR017 infusion to progressive disease (PD) or death. Kaplan-Meier (KM) methodology will be used to analyze PFS.

    PD = Score 4 or 5b on the positron emission tomography 5-point scale (PET 5PS) with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

    PET 5PS = 1- no uptake above background; 2- uptake ≤ mediastinum; 3- uptake > mediastinum but ≤ liver; 4- uptake moderately > liver; 5- uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

    Measured: From first dose to progressive disease (PD) or death (up to approximately 24 months)

  12. Event-Free Survival (EFS)

    EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS.

    PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment.

    PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake > mediastinum but ≤ liver; 4-uptake moderately > liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.

    Measured: From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)

  13. Overall Survival (OS)

    OS is defined as the time from JCAR017 infusion to the date of death. Kaplan-Meier (KM) methodology will be used to analyze OS.

    Measured: From first dose to date of death (up to approximately 24 months)

  14. PK Parameters of JCAR017 in Blood as Assessed by qPCR: Cmax

    Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR).

    Cmax = Maximum observed blood concentration.

    Measured: From first dose to up to 24 months

  15. PK Parameters of JCAR017 in Blood as Assessed by qPCR: Tmax

    Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). Tmax = Time of maximum observed blood concentration.

    Measured: From first dose to up to 24 months

  16. PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)

    Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.

    Measured: From first dose to up to 24 months

  17. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  18. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

    Measured: Baseline and Day 29

  19. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

    Measured: Baseline and Day 29

  20. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health/QoL Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

    Measured: Baseline and Day 29

  21. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

    Measured: Baseline and Day 29

  22. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

    Measured: Baseline and Day 29

  23. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

    Measured: Baseline and Day 29

  24. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  25. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea/Vomiting Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  26. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  27. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  28. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  29. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  30. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Symptom scale/item higher score represents a high level of symptomatic problem.

    Measured: Baseline and Day 29

  31. Mean Score in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties Subscale

    • Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
    • The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
    • All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL.
    • Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning.

    Measured: Baseline and Day 29

  32. Health-Related Quality of Life (HRQoL) Assessed by the FACT-Lym Subscale

    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. 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.

    Measured: Baseline and Day 29

  33. Health-Related Quality of Life (HRQoL) Assessed by the EuroQol Instrument EQ-5D-5L

    The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-5L health states ranged from -.594 for the worst (55555) to 1 for the best (11111) for UK value set with an optimal health state is assigned a score of 1.00, death is assigned a score of 0.00 and negative values representing values as worse than dead. A change of .08 is considered to be a clinically meaningful change in health utility.

    Measured: Baseline and Day 29

  34. Numbers of Intensive Care Unit (ICU) Inpatient Days

    The numbers of ICU inpatient days.

    Measured: From first dose after JCAR017 infusion to up to approximately 24 months

  35. Numbers of Non-intensive Care Unit (ICU) Inpatient Days

    Number of non-ICU inpatient days.

    Measured: From first dose after JCAR017 infusion to up to approximately 24 months

  36. The Number of Participants That Were Hospitalized For Adverse Events, Prophylaxis, Other

    Length of hospitalization stay was reported for up to 24 months post liso-cel infusion. Reasons for hospitalization include adverse events, prophylaxis, and other. Adverse events were reported for up to 90 days post liso-cel infusion.

    Measured: From first dose after JCAR017 infusion to up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start27 Jul 2018
  3. Primary completion24 Sep 2021
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03483103
Sponsor's protocol ID
017006
Status last verified
Nov 2023
First submitted
23 Mar 2018
Last updated
20 Dec 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston ND, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta NK, Chow VA, Yuan B, Yang Z, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel for R/R LBCL in patients not intended for HSCT: final results of the phase 2 PILOT study. Blood Adv. 2025 Aug 12;9(15):3694-3705. doi: 10.1182/bloodadvances.2024015262.

    PubMed 40305658

  • Ghosh N, Sehgal A, Liu FF, Kostic A, Crotta A, De Benedetti M, Faccone J, Peng L, Gordon LI. Comparative efficacy of lisocabtagene maraleucel in the PILOT study versus second-line chemotherapy regimens in the real world. Haematologica. 2025 Mar 1;110(3):693-705. doi: 10.3324/haematol.2024.285828.

    PubMed 39479862

  • Gordon LI, Liu FF, Braverman J, Hoda D, Ghosh N, Hamadani M, Hildebrandt GC, Peng L, Guo S, Shi L, Sehgal A. Lisocabtagene maraleucel for second-line relapsed or refractory large B-cell lymphoma: patient-reported outcomes from the PILOT study. Haematologica. 2024 Mar 1;109(3):857-866. doi: 10.3324/haematol.2023.283162.

    PubMed 37646670

  • Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston N, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta N, Dubowy R, D'Andrea A, Wang L, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1066-1077. doi: 10.1016/S1470-2045(22)00339-4. Epub 2022 Jul 12.

    PubMed 35839786

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PubMed 34515338

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lisocabtagene maraleucel in people with Lymphoma, Non-Hodgkin and Lymphoma, Nonhodgkin, run by Juno Therapeutics, a Subsidiary of Celgene at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03483103, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.

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