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NCT00920972 · ClinicalTrials.gov registry record · Phase 1

Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases

A Phase 1 study of Hemoglobinopathies and Metabolic Disorders, sponsored by Washington University School of Medicine.

Recruiting
Registry status
Phase 1
Development phase
220
Enrollment target
20
Study locations

NCT00920972 is a Phase 1 study of Hemoglobinopathies and Metabolic Disorders that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 220 participants, below the 1,791-participant average among 17 other Hemoglobinopathies trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00920972, a Phase 1 study of Hemoglobinopathies and Metabolic Disorders, is actively recruiting participants, sponsored by Washington University School of Medicine.

RECRUITING
Registry status
Phase 1
Development phase
220 participants
Enrollment target
20
Study locations

Study Summary

The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.

Interventions

  • DRUG Treatment Plan 1: Stratum 1
  • DRUG Treatment Plan 2: Strata 2, 3, or 4
  • DRUG GVHD Regimen A: UCB Recipients
  • DRUG GVHD Regimen B: BM Recipients

Study Locations (20)

Florida

  • Nemours Children's Health - Jacksonville
  • University of Miami - Miami
  • Miami Children's Hospital - Miami
  • All Children's Hospital - St. Petersburg

Missouri

  • Children's Mercy - Kansas City
  • St. Louis University - St Louis
  • Washington University School of Medicine (in St. Louis) - St Louis

North Carolina

  • University of North Carolina - Chapel Hill
  • Carolinas Medical Center - Charlotte
  • Duke Children's Hospital - Durham

California

  • Children's Hospital of Orange County - Orange
  • University of California - San Diego

Arizona

  • Phoenix Children's Hospital - Phoenix

Connecticut

  • Yale School of Medicine - New Haven

District of Columbia

  • George Washington University School of Medicine - Washington D.C.

Illinois

  • Children's Memorial Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2001-12
Est. Completion 2031-12
Phase Phase 1

What the Registry Record Tells You About NCT00920972

The ClinicalTrials.gov registry entry for NCT00920972 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,791-participant average among 17 other Hemoglobinopathies trials with a reported enrollment target (88% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Hemoglobinopathies appearing as the primary indexed condition, and to 4 interventions - of which Treatment Plan 1: Stratum 1 is the first listed.

NCT00920972 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Missouri, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00920972 about?

NCT00920972 is a clinical study titled "Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases". The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 ...

What is the current status of trial NCT00920972?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2001-12. Estimated completion is 2031-12.

What conditions does trial NCT00920972 study?

This clinical trial studies the following conditions: Hemoglobinopathies, Metabolic Disorders, Non-malignant Disorders, Hematologic, Immune, or Bone Marrow Disorders.

What interventions are being tested in trial NCT00920972?

The interventions under investigation include: Treatment Plan 1: Stratum 1 (DRUG), Treatment Plan 2: Strata 2, 3, or 4 (DRUG), GVHD Regimen A: UCB Recipients (DRUG), GVHD Regimen B: BM Recipients (DRUG).

Who is sponsoring clinical trial NCT00920972?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00920972 being conducted?

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