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Trial record 1 of 1 for:    NCT03484702
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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 : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE April 2, 2018
Last Update Posted Date January 26, 2022
Actual Study Start Date  ICMJE June 5, 2018
Estimated Primary Completion Date January 14, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2022)
  • 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 ]
  • 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 ]
  • Adverse Events (AEs) in participants intended to be treated as outpatients [ Time Frame: Up to 2 years after JCAR017 infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Overall Response Rate (ORR) of JCAR017 in subjects with Non-Hodgkin Lymphoma (NHL; including secondary central nervous system (CNS) involvement) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Proportion of subjects achieving a complete response (CR) or partial response (PR) based on the Lugano classification (Cheson, 2014)
  • ORR of JCAR017 in subjects with relapsed/refractory (r/r) primary central nervous system lymphoma (PCNSL) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Proportion of subjects achieving a CR/complete response unconfirmed (CRu) or PR based on the International Workshop to Standardize Baseline Evaluation and Response Criteria in Primary CNS Lymphoma (Abrey, 2005)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2022)
  • Incidence of Adverse Events [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Incidence of Serious Adverse Events [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Adverse Events (AEs) in participants treated as outpatients [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Overall Response Rate (ORR) in participants intended to be treated as outpatients [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Complete Response Rate (CRR) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Event-free survival (EFS) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Overall survival (OS) [ Time Frame: Up to last participant last visit (approximately 40 months) ]
  • Duration of response (DOR) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Pharmacokinetics by quantitative polymerase chain reaction (qPCR) - Maximum plasma concentration of drug (Cmax) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Pharmacokinetics by qPCR - Time to peak concentration (Tmax) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • Pharmacokinetics by qPCR - Area under the curve (AUC) [ Time Frame: Up to 2 years after JCAR017 infusion ]
  • 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 ]
  • Patient-Reported Outcomes - Functional Assessment of Cancer Therapy-Lymphoma "Additional concerns" subscale [ Time Frame: Up to 2 years after JCAR017 infusion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2018)
  • Adverse Events (AEs) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Type, frequency, and severity of AEs, including serious adverse events (SAEs) and laboratory abnormalities
  • Overall Response Rate (ORR)on the underlying chronic lymphocytic leukemia (CLL) in subjects with Richter´s transformation [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Proportion of subjects achieving a CR, CR with incomplete bone marrow recovery (CRi), nodular PR (nPR), PR or PR with lymphocytosis (PRL) based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines
  • Complete response rate (CRR) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Proportion of subjects achieving a CR (or CR and CRu for subjects with PCNSL) following JCAR017 infusion
  • Event-free survival (EFS) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Time from JCAR017 infusion to death from any cause, progressive disease (PD), or starting a new anticancer therapy, whichever occurs first
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Time from JCAR017 infusion to the first documentation of PD, or death due to any cause, whichever occurs first
  • Overall survival (OS) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Time from JCAR017 infusion to time of death due to any cause
  • Duration of response (DOR) [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Time from first response to progressive disease or death from any cause, whichever occurs first
  • Pharmacokinetic - Cmax [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Maximum concentration
  • Pharmacokinetic - Tmax [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Time to peak concentration
  • Pharmacokinetic - AUC [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Area under the curve
  • Patient-Reported Outcomes - EORTC QLQ-C30 [ Time Frame: Up to 2 years after JCAR017 infusion ]
    European Organisation for Research and Treatment of Cancer - Quality of Life C30 questionnaire: The EORTC QLQ-C30 questionnaire will be used as a measure of health-related quality of life.
  • Patient-Reported Outcomes - EQ-5D-5L [ Time Frame: Up to 2 years after JCAR017 infusion ]
    European Quality of Life-5 Dimensions health state classifier to 5 Levels questionnaire: EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal.
  • Patient-Reported Outcomes - FACT-Lym [ Time Frame: Up to 2 years after JCAR017 infusion ]
    Functional Assessment of Cancer Therapy-Lymphoma "Additional concerns" subscale: Only the LYM subscale will be administered in this study. This scale addresses symptoms and functional limitations (15 item) that are important to lymphoma patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
Official Title  ICMJE 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
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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Non-Hodgkin
Intervention  ICMJE Drug: JCAR017
Specified dose on specified days
Other Name: Lisocabtagene Maraleucel (liso-cel)
Study Arms  ICMJE Experimental: Administration of JCAR017
Intervention: Drug: JCAR017
Publications * 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:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 21, 2022)
112
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2018)
124
Estimated Study Completion Date  ICMJE January 14, 2024
Estimated Primary Completion Date January 14, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Finland,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03484702
Other Study ID Numbers  ICMJE JCAR017-BCM-001
U1111-1209-4055 ( Other Grant/Funding Number: WHO )
2017-000106-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Celgene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Celgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Celgene
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP