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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: Active Phase 2 study of Lymphoma, Non-Hodgkin, sponsored by Celgene.
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 384-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2031-09-30 |
| Phase | Phase 2 |
What the registry record for NCT04245839 still lists
NCT04245839 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 384-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (28% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
Similar trials for Lymphoma, Non-Hodgkin
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04245839's enrollment target sits among peer trials
276 15th of 58 higher than 44 of 58 other Lymphoma, Non-Hodgkin trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, Non-Hodgkin trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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