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NCT02208037 · ClinicalTrials.gov registry record · Phase 2

Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)

A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Completed
Registry status
Phase 2
Development phase
279
Enrollment target
20
Study locations

NCT02208037 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 279 participants, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT02208037, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Registry status
Phase 2
Development phase
279 participants
Enrollment target
20
Study locations

Study Summary

Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after transplant compared to the current standard prophylaxis regimen.

Interventions

  • DRUG Maraviroc
  • DRUG Tacrolimus (ARM with Methotrexate)
  • DRUG Tacrolimus (ARM with MMF and Cyclophosphamide)
  • DRUG Methotrexate (ARM with Maraviroc)
  • DRUG Methotrexate (ARM with Bortezomib)

Study Locations (20)

California

  • City of Hope National Medical Center - Duarte
  • Stanford Hospital and Clinics - Stanford

Florida

  • University of Florida College of Medicine (Shands) - Gainesville
  • H. Lee Moffitt Cancer Center - Tampa

Georgia

  • Emory University - Atlanta
  • BMT Program at Northside Hospital - Atlanta

Massachusetts

  • Dana Farber Cancer Institute/Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute/Brigham & Women's - Boston

Minnesota

  • University of Minnesota - Minneapolis
  • Mayo Clinic - Rochester - Rochester

New York

  • Roswell Park Cancer Institute - Buffalo
  • Memorial Sloan-Kettering Cancer Center - Manhattan

Illinois

  • Loyola University Medical Center - Maywood

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Trial Details

FieldValue
Enrollment Target 279 participants
Start Date 2014-08
Est. Completion 2017-10
Phase Phase 2

What the Registry Record Tells You About NCT02208037

The ClinicalTrials.gov registry entry for NCT02208037 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (55% higher). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Maraviroc is the first listed.

NCT02208037 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT02208037 about?

NCT02208037 is a clinical study titled "Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)". Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after ...

What is the current status of trial NCT02208037?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 279 participants. The study started on 2014-08. Estimated completion is 2017-10.

What conditions does trial NCT02208037 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Acute Leukemia, Lymphoma, B-Cell, Chronic Myelogenous Leukemia.

What interventions are being tested in trial NCT02208037?

The interventions under investigation include: Maraviroc (DRUG), Tacrolimus (ARM with Methotrexate) (DRUG), Tacrolimus (ARM with MMF and Cyclophosphamide) (DRUG), Methotrexate (ARM with Maraviroc) (DRUG), Methotrexate (ARM with Bortezomib) (DRUG).

Who is sponsoring clinical trial NCT02208037?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02208037 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.