Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03483103 |
Recruitment Status :
Completed
First Posted : March 30, 2018
Results First Posted : December 29, 2022
Last Update Posted : January 13, 2023
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Sponsor:
Juno Therapeutics, a Subsidiary of Celgene
Information provided by (Responsible Party):
Juno Therapeutics, a Subsidiary of Celgene
- Study Details
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- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Lymphoma, Non-Hodgkin Lymphoma, Nonhodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse |
Intervention |
Biological: lisocabtagene maraleucel |
Enrollment | 74 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | All efficacy and safety analyses were conducted on the JCAR017-treated Analysis Set. |
Arm/Group Title | Lisocabtagene Maraleucel (JCAR017) |
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Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. |
Period Title: Pre-Treatment Phase | |
Started [1] | 74 |
Completed [2] | 63 |
Not Completed | 11 |
Reason Not Completed | |
Other reasons | 1 |
No longer meets eligibility criteria | 4 |
Disease-related complications | 1 |
Death | 5 |
[1]
Participants who underwent leukapheresis
[2]
Participants who completed leukapheresis and continued to lymphodepleting chemotherapy (LDC) treatment period
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Period Title: Treatment Phase | |
Started [1] | 63 |
Received JCAR017 | 61 |
Received Nonconforming Product | 1 |
Did Not Receive Either JAR017 or Nonconforming Product | 1 |
Completed [2] | 7 |
Not Completed | 56 |
Reason Not Completed | |
Withdrawal by Subject | 6 |
Other reasons | 2 |
Death | 20 |
Ongoing in study | 26 |
Did not receive either JAR017 or nonconforming product | 1 |
Received nonconforming product | 1 |
[1]
Participants who underwent lymphodepleting chemotherapy (LDC) treatment
[2]
Completed study
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Baseline Characteristics
Arm/Group Title | Lisocabtagene Maraleucel (JCAR017) | |
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Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy. | |
Overall Number of Baseline Participants | 74 | |
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74 participants were leukapheresed.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 74 participants | |
72.8 (6.57) | ||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 74 participants | |
< 65 years |
8 10.8%
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>= 65 to < 70 years |
7 9.5%
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>= 70 to < 75 years |
27 36.5%
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>= 75 years |
32 43.2%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 74 participants | |
Female |
29 39.2%
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Male |
45 60.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 74 participants | |
Hispanic or Latino |
1 1.4%
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Not Hispanic or Latino |
64 86.5%
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Unknown or Not Reported |
9 12.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 74 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
2 2.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
2 2.7%
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White |
64 86.5%
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More than one race |
0 0.0%
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Unknown or Not Reported |
6 8.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: | Bristol-Myers Squibb Study Director |
Organization: | Bristol-Myers Squibb |
Phone: | 855-907-3286 |
EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Juno Therapeutics, a Subsidiary of Celgene |
ClinicalTrials.gov Identifier: | NCT03483103 |
Other Study ID Numbers: |
017006 |
First Submitted: | March 23, 2018 |
First Posted: | March 30, 2018 |
Results First Submitted: | September 23, 2022 |
Results First Posted: | December 29, 2022 |
Last Update Posted: | January 13, 2023 |