Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245839
Recruitment Status : Not yet recruiting
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

  • Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
  • Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
  • Posttreatment, which includes follow-up assessments for disease status and safety for 2 years.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Single Arm, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 (Lisocabtagene Maraleucel) in Adult Subjects With High-risk, Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Estimated Study Start Date : April 3, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : June 17, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Fludarabine

Arm Intervention/treatment
Experimental: Administration of JCAR017
  • Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents.
  • JCAR017 will be infused on Day 1 at a dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Drug: Fludarabine
Fludarabine

Drug: Cyclophosphamide
Cyclophosphamide

Drug: JCAR017
JCAR017




Primary Outcome Measures :
  1. Complete Response Rate (CRR) [ Time Frame: Up to 24 months ]
    is defined as the percentage of subjects achieving a complete response (CR) at any time up to 24 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification".


Secondary Outcome Measures :
  1. Overall response rate (ORR) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
    is defined as the percentage of subjects achieving a response (CR or PR) at any time up to 24 months after JCAR017 treatment

  2. Duration of response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
    is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 24 months after JCAR017 treatment

  3. Duration of response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
    is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 24 months after JCAR017 treatment

  4. Progression-free survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
    is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 24 months after JCAR017 treatment

  5. Overall Survival (OS) [ Time Frame: Up to 24 months ]
    is defined as the time from start of JCAR017 to time of death due to any cause up to 24 months after JCAR017 treatment

  6. Adverse Events (AEs) [ Time Frame: Up to 24 months ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

  7. Pharmacokinetics - Cmax [ Time Frame: Up to 24 months ]
    Maximum concentration

  8. Pharmacokinetics - Tmax [ Time Frame: Up to 24 months ]
    Time to maximum concentration

  9. Pharmacokinetics - AUC [ Time Frame: Up to 24 months ]
    Area under the curve

  10. European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) [ Time Frame: Up to 24 months ]

    is questionnaire that will be used as a measure of health-related quality of life.

    The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.


  11. Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS) [ Time Frame: Up to 24 months ]
    is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS 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. High scores indicate lower symptom burden.



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.


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

Inclusion Criteria:

  1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
  2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
  3. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one or two prior lines of systemic therapy are eligible if they present with high risk features. Patients that received three or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
  4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate organ function
  7. Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

  1. Evidence of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
  2. WHO subclassification of duodenal-type FL
  3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
  4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
  5. Prior CAR T-cell or other genetically-modified T-cell therapy
  6. History of or active human immunodeficiency virus (HIV)
  7. Active hepatitis B or active hepatitis C
  8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
  9. Active autoimmune disease requiring immunosuppressive therapy
  10. Presence of acute or chronic graft-versus-host=disease
  11. History of significant cardiovascular disease
  12. History or presence of clinically relevant central nervous system pathology

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): NCT04245839


Contacts
Layout table for location contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Thalia Farazi, M.D./Ph.D Celgene Medical Director

Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04245839    
Other Study ID Numbers: JCAR017-FOL-001
U1111-1244-9768 ( Other Identifier: WHO )
2019-004081-18 ( EudraCT Number )
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
B-cell Non-Hodgkin Lymphoma (NHL)
JCAR017
Relapsed or Refractory
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites