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NCT03394365 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

A Phase 3 study of Stem Cell Transplant Complications and Lymphoproliferative Disorders, sponsored by Pierre Fabre Medicament.

Recruiting
Registry status
Phase 3
Development phase
115
Enrollment target
20
Study locations

NCT03394365 is a Phase 3 study of Stem Cell Transplant Complications and Lymphoproliferative Disorders that is actively recruiting participants, run by Pierre Fabre Medicament. The registered enrollment target is 115 participants, below the 178-participant average among 15 other Stem Cell Transplant Complications trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT03394365, a Phase 3 study of Stem Cell Transplant Complications and Lymphoproliferative Disorders, is actively recruiting participants, sponsored by Pierre Fabre Medicament.

RECRUITING
Registry status
Phase 3
Development phase
115 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Conditions Studied

Stem Cell Transplant Complications Lymphoproliferative Disorders Solid Organ Transplant Complications Allogeneic Hematopoietic Cell Transplant Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)

Interventions

  • BIOLOGICAL tabelecleucel

Study Locations (20)

California

  • City of Hope (Adults and Pediatrics) - Duarte
  • University of California San Diego Moores Cancer Center (Adults only) - La Jolla
  • Loma Linda University Medical Center (Adults only) - Loma Linda
  • Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics) - Los Angeles
  • UCLA Medical Center (Adults and Pediatrics) - Los Angeles
  • University of California Davis Comprehensive Cancer Center (Adults only) - Sacramento

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics) - Chicago
  • University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only) - Chicago
  • Loyola University Medical Center (Adults and Pediatrics) - Maywood

Florida

  • University of Florida (Adults and Pediatrics) - Gainesville
  • University of Miami/Jackson Memorial Hospital (Adults only) - Miami

Georgia

  • Winship Cancer Institute (Adults only) - Atlanta
  • Arthur M. Blank Hospital (Pediatrics) - Atlanta

New York

  • Weill Cornell Medicine (Adults only) - New York
  • Columbia University Medical Center (Adults and Pediatrics) - New York

Connecticut

  • Yale University (Adults and Pediatrics) - New Haven

District of Columbia

  • MedStar Georgetown University Hospital (Adults and Pediatrics) - Washington D.C.

Maryland

  • University of Maryland School of Medicine (Adults only) - Baltimore

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2017-12-29
Est. Completion 2030-08
Phase Phase 3

Sponsor

Pierre Fabre Medicament

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03394365

The ClinicalTrials.gov registry entry for NCT03394365 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 15 other Stem Cell Transplant Complications trials with a reported enrollment target (35% lower). The listed sponsor is Pierre Fabre Medicament, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Stem Cell Transplant Complications appearing as the primary indexed condition, and to 1 intervention - of which tabelecleucel is the first listed.

NCT03394365 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, Florida.

Frequently Asked Questions

What is clinical trial NCT03394365 about?

NCT03394365 is a clinical study titled "A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy". The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab...

What is the current status of trial NCT03394365?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 115 participants. The study started on 2017-12-29. Estimated completion is 2030-08.

What conditions does trial NCT03394365 study?

This clinical trial studies the following conditions: Stem Cell Transplant Complications, Lymphoproliferative Disorders, Solid Organ Transplant Complications, Allogeneic Hematopoietic Cell Transplant, Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD).

What interventions are being tested in trial NCT03394365?

The interventions under investigation include: tabelecleucel (BIOLOGICAL).

Who is sponsoring clinical trial NCT03394365?

This trial is sponsored by Pierre Fabre Medicament, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03394365 being conducted?

This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. 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.