A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)
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|ClinicalTrials.gov Identifier: NCT03744676|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : June 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Disorder||Biological: lisocabtagene maraleucel||Phase 2|
This is an open-label, multicenter, Phase 2 study to assess the safety and antitumor activity in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered with lisocabtagene maraleucel (JCAR017) in the outpatient setting.
Upon the successful product generation of lisocabtagene maraleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by lisocabtagene maraleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, health-related quality of life (HRQoL), and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, per health regulatory authority guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting|
|Actual Study Start Date :||November 29, 2018|
|Estimated Primary Completion Date :||October 30, 2023|
|Estimated Study Completion Date :||October 30, 2023|
Experimental: Lisocabtagene maraleucel
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of lisocabtagene maraleucel. During lisocabtagene maraleucel production, subjects may receive low-dose chemotherapy for disease control. Upon successful generation of lisocabtagene maraleucel product, subjects will receive treatment which will include lymphodepleting chemotherapy followed by one dose of lisocabtagene maraleucel administered by intravenous (IV) injection.
Biological: lisocabtagene maraleucel
lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection
- Adverse events [ Time Frame: Through Month 24 ]Proportion of subjects experiencing cytokine release syndrome, neurotoxicity, prolonged cytopenias, infections AE of Grade 3 or higher
- Adverse events [ Time Frame: Through Month 24 ]Proportion of subjects experiencing all AEs and laboratory abnormalities
- Adverse events [ Time Frame: Through Month 24 ]Median time to onset and to resolution of cytokine release syndrome and neurotoxicity of Grade 3 or higher
- Adverse Events [ Time Frame: Through Month 24 ]Management of cytokine release syndrome and neurotoxicity
- Adverse Events [ Time Frame: Through Month 24 ]Of subjects monitored in the outpatient setting, the proportion of subjects experiencing all AEs and laboratory abnormalities
- Objective response rate (ORR) [ Time Frame: Through Month 24 ]Objective response rate (ORR [complete response + partial response]) according to the Lugano Classification
- Complete response (CR) rate [ Time Frame: Through Month 24 ]Complete response rate according to the Lugano Classification
- Duration of response (DOR) and duration of complete response (DoCR) [ Time Frame: Through Month 24 ]Each defined as time from first response to progressive disease (PD) or death
- Progression-free Survival (PFS) [ Time Frame: Through Month 24 ]Time from infusion of lisocabtagene maraleucel to PD or death, whichever is earlier
- Overall Survival (OS) [ Time Frame: Through Month 24 ]Defined as the time from infusion of lisocabtagene maraleucel to the date of death
- Pharmacokinetics- Maximum concentration (Cmax) [ Time Frame: Through Month 24 ]Maximum concentration of lisocabtagene maraleucel
- Pharmacokinetics- Time of the maximum concentration (Tmax) [ Time Frame: Through Month 24 ]Time to peak concentration of lisocabtagene maraleucel in the blood
- Pharmacokinetics- area under the curve [ Time Frame: Through Month 24 ]Area under the curve of lisocabtagene maraleucel in blood
- Health-related quality of life questionnaires [ 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.
- Health-related quality of life questionnaires [ 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 economics and outcomes research [ Time Frame: Through Month 24 ]For subjects hospitalized post-treatement, the number of days the subjects were hospitalized, including the number of days that the subjects were in the Intensive Care Unit (ICU) and non-ICU ward
- Health economics and outcomes research [ Time Frame: Through Month 24 ]The percentage of lisocabtagene maraleucel-treated subjects hospitalized post-treatment for each reason will be reported.
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): NCT03744676
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|Study Director:||Ricardo Espinola, MD||Bristol-Myers Squibb|