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RECRUITING Phase 1

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

NCT00920972 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00920972

The ClinicalTrials.gov registry entry for NCT00920972 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00920972 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Missouri, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00920972?

This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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