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NCT01772953 · ClinicalTrials.gov registry record · Phase 2

Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT

A Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Center for International Blood and Marrow Transplant Research.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target
20
Study locations

NCT01772953 is a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that has completed, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 40 participants, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT01772953, a Phase 2 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), has completed, sponsored by Center for International Blood and Marrow Transplant Research.

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

Study Summary

This is a prospective, open-label, nonrandomized, prospective clinical trial evaluating a fixed regimen of treosulfan, fludarabine and low-dose total body irradiation (TBI) in children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT). The primary hypothesis is that HCT with a preparative regimen consisting of treosulfan, fludarabine and low-dose TBI will result in overall survival (OS) comparable to historical rates observed with conventional myeloablative regimens in the pediatric population. The preparative regimen will result in adequate incidence of neutrophil and platelet engraftment, and acceptable rates of graft-versus-host disease (GVHD), relapse and survival. The pharmacokinetic (PK) profile of treosulfan in children will be comparable to that of adults previously studied.

Conditions Studied

Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS)

Interventions

  • DRUG Treosulfan

Study Locations (20)

Ohio

  • University Hospitals Case Medical Center - Cleveland
  • Cleveland Clinic - Cleveland
  • Nationwide Children's Hospital - Columbus

California

  • City of Hope - Duarte
  • Children's Hospital Los Angeles - Los Angeles

Missouri

  • Children's Mercy Hospital - Kansas City
  • Washington University, St. Louis Children's - St Louis

Alabama

  • Children's Hospital of Alabama/UAB - Birmingham

Arizona

  • Phoenix Children's Hospital - Phoenix

Colorado

  • Children's Hospital of Colorado - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Florida

  • All Children's Hospital - St. Petersburg

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2013-09
Est. Completion 2015-08
Phase Phase 2

Sponsor

Center for International Blood and Marrow Transplant Research

29 total trials

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What the Registry Record Tells You About NCT01772953

The ClinicalTrials.gov registry entry for NCT01772953 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (72% lower). The listed sponsor is Center for International Blood and Marrow Transplant Research, which has 29 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 1 intervention - of which Treosulfan is the first listed.

NCT01772953 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Ohio, California, Missouri.

Frequently Asked Questions

What is clinical trial NCT01772953 about?

NCT01772953 is a clinical study titled "Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT". This is a prospective, open-label, nonrandomized, prospective clinical trial evaluating a fixed regimen of treosulfan, fludarabine and low-dose total body irradiation (TBI) in children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell trans...

What is the current status of trial NCT01772953?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-09. Estimated completion is 2015-08.

What conditions does trial NCT01772953 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS).

What interventions are being tested in trial NCT01772953?

The interventions under investigation include: Treosulfan (DRUG).

Who is sponsoring clinical trial NCT01772953?

This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01772953 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. 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.