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 : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin Lymphoma, Nonhodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse||Biological: lisocabtagene maraleucel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
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 will be administered as a single dose intravenous (IV) injection
- 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"
- 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
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
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|Study Director:||Nick Trede, MD, PhD||Juno Therapeutics, Inc.|