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Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma (TRANSCENDWORLD)

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: NCT03484702
Recruitment Status : Active, not recruiting
First Posted : April 2, 2018
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of JCAR017 in participants with aggressive B-cell non-Hodgkin lymphoma (B-NHL)

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: JCAR017 Phase 2

Detailed Description:

This is a study to determine the efficacy and safety of JCAR017 in adult participants with aggressive B-cell NHL. The study will enroll participants in Europe and Japan with 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 (HGBL), follicular lymphoma Grade 3B (FL3B), and primary central nervous system lymphoma (PCNSL). Participants with secondary central nervous system (CNS) involvement are allowed.

Once enrolled, participants will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered by intravenous infusion. Participants will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life.

Delayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-arm, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or With Other Aggressive B-Cell Malignancies
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : December 9, 2023
Estimated Study Completion Date : December 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Administration of JCAR017 Drug: JCAR017
Specified dose on specified days
Other Name: Lisocabtagene Maraleucel (liso-cel)


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) of JCAR017 in participants with Non-Hodgkin Lymphoma (NHL; including secondary central nervous system (CNS) involvement) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  2. ORR of JCAR017 in participants with relapsed/refractory (r/r) primary central nervous system lymphoma (PCNSL) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  3. Adverse Events (AEs) in participants intended to be treated as outpatients [ Time Frame: Up to 2 years after JCAR017 infusion ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Up to 2 years after JCAR017 infusion ]
  2. Incidence of Serious Adverse Events [ Time Frame: Up to 2 years after JCAR017 infusion ]
  3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2 years after JCAR017 infusion ]
  4. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 2 years after JCAR017 infusion ]
  5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 2 years after JCAR017 infusion ]
  6. Adverse Events (AEs) in participants treated as outpatients [ Time Frame: Up to 2 years after JCAR017 infusion ]
  7. Overall Response Rate (ORR) in participants intended to be treated as outpatients [ Time Frame: Up to 2 years after JCAR017 infusion ]
  8. Complete Response Rate (CRR) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  9. Event-free survival (EFS) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  10. Progression-free survival (PFS) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  11. Overall survival (OS) [ Time Frame: Up to last participant last visit (approximately 40 months) ]
  12. Duration of response (DOR) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  13. Pharmacokinetics by quantitative polymerase chain reaction (qPCR) - Maximum plasma concentration of drug (Cmax) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  14. Pharmacokinetics by qPCR - Time to peak concentration (Tmax) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  15. Pharmacokinetics by qPCR - Area under the curve (AUC) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  16. Patient-Reported Outcomes - European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire [ Time Frame: Up to 2 years after JCAR017 infusion ]
  17. Patient-Reported Outcomes - Functional Assessment of Cancer Therapy-Lymphoma "Additional concerns" subscale [ Time Frame: Up to 2 years after JCAR017 infusion ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmation of diagnosis at last relapse
  • Adequate organ function
  • Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

  • Prior history of malignancies, other than aggressive relapsed/refractory Non-Hodgkin Lymphoma, unless the participant has been in remission for ≥ 2 years with the exception of non-invasive malignancies
  • Received previous CD19-targeted therapy
  • Progressive vascular tumor invasion, thrombosis, or embolism

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

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): NCT03484702


Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03484702    
Other Study ID Numbers: JCAR017-BCM-001
U1111-1209-4055 ( Other Grant/Funding Number: WHO )
2017-000106-38 ( EudraCT Number )
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Celgene:
Non-Hodgkin lymphoma
Aggressive B-cell non-Hodgkin lymphoma
Diffuse large B-cell lymphoma
Relapse / refractory lymphoma
Transplant not eligible
High-grade B-cell lymphoma
 Primary central nervous system lymphoma
Transformed follicular lymphoma
Follicular lymphoma Grade 3B
JCAR017
Liso-Cel
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Aggression
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms