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NCT04245839 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lymphoma, Non-Hodgkin, sponsored by Celgene.

Active
Registry status
Phase 2
Development phase
276
Enrollment target
20
Study locations

NCT04245839 is a Phase 2 study of Lymphoma, Non-Hodgkin that is active but no longer recruiting, run by Celgene. The registered enrollment target is 276 participants, below the 389-participant average among 56 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT04245839, a Phase 2 study of Lymphoma, Non-Hodgkin, is active but no longer recruiting, sponsored by Celgene.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
276 participants
Enrollment target
20
Study locations

Study 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 5 years.

Conditions Studied

Lymphoma, Non-Hodgkin

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG JCAR017

Study Locations (20)

Illinois

  • Local Institution - 103 - Chicago
  • Local Institution - 109 - Niles

Massachusetts

  • Local Institution - 100 - Boston
  • Local Institution - 101 - Boston

Texas

  • Local Institution - 121 - Dallas
  • Local Institution - 104 - Houston

California

  • Local Institution - 111 - Santa Monica

Colorado

  • Local Institution - 107 - Aurora

Connecticut

  • Local Institution - 105 - New Haven

Iowa

  • Local Institution - 122 - Iowa City

Kansas

  • Local Institution - 124 - Wichita

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2020-07-14
Est. Completion 2031-09-30
Phase Phase 2

Sponsor

Celgene

308 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04245839

The ClinicalTrials.gov registry entry for NCT04245839 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 389-participant average among 56 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (29% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.

NCT04245839 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Illinois, Massachusetts, Texas.

Frequently Asked Questions

What is clinical trial NCT04245839 about?

NCT04245839 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)". 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 Registratio...

What is the current status of trial NCT04245839?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 276 participants. The study started on 2020-07-14. Estimated completion is 2031-09-30.

What conditions does trial NCT04245839 study?

This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin.

What interventions are being tested in trial NCT04245839?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), JCAR017 (DRUG).

Who is sponsoring clinical trial NCT04245839?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04245839 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.