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Protocol # 20-011

Status

Recruiting

Description

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 5 years.

Condition

  • Lymphoma, Non-Hodgkin

Interventions

  • Fludarabine
  • Cyclophosphamide
  • JCAR017

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall Response Rate (ORR)

Secondary Outcome:

  • Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"
  • Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"
  • Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"
  • Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"
  • Overall Survival (OS)
  • Adverse Events (AEs)
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - Tmax
  • Pharmacokinetics - AUC
  • European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
  • Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)

Enrollment

213

Study Start Date

July 14, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Celgene

Source

Celgene

Official title

A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Clinicaltrials.gov Identifier

NCT04245839

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.