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NCT00578643 · ClinicalTrials.gov registry record · Phase 2

Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease

A Phase 2 study of Chronic Granulomatous Disease, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 2
Development phase
15
Enrollment target
1
Study location

NCT00578643: Completed Phase 2 study of Chronic Granulomatous Disease, sponsored by Baylor College of Medicine.

NCT00578643 is a Phase 2 study of Chronic Granulomatous Disease that has completed, run by Baylor College of Medicine. The registered enrollment target is 15 participants, below the 32-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00578643, a Phase 2 study of Chronic Granulomatous Disease, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

This study is for patients with chronic granulomatous disease (CGD), which is a disorder of the immune system that puts them at risk for severe infections. CGD is caused by a genetic defect that stops or prevents the white blood cells from killing certain bacteria and fungi. This condition cannot presently be cured by standard treatment with drugs or surgery. Medicine including antibiotics, antifungals, and interferon gamma, may help some patients with CGD; however even with continuous treatment, most patients with CGD will have chronic and recurrent infections. Transfusion of white blood cells may help overcome infection, but white cell transfusions lead to allergic reactions and fever and the benefit of transfusion lasts only a matter of hours. Ultimately, chronic infections can damage or injure the body organs. Injury to the lung or liver can lead to lung or liver failure and death. Medicines used to treat infection can damage body organs too. Infections may become resistant to antibiotic or antifungal treatment, and infections not responding to treatment can be deadly. It is now known that under specific conditions and with special treatment, blood stem cells (the cells that make blood) can be transplanted from one person to another. Stem cell transplantation has been done for patients with CGD who have a healthy sibling and who share the same immune type (HLA type) as the patient. Stem cell transplantation allows healthy or normal white cells from the stem cell donor to grow or develop in the patient's bone marrow. These healthy white cells can fight infection and prevent future infections for a patient with CGD. Patients on this study will receive stem cells from a related or unrelated donor. The donor will be closely matched to the patient's immune type but the donor is not a sibling. The reason this treatment is investigational is that we do not know the likelihood of benefit that the patient will receive. It is possible that they will have great benefit,

Primary Outcome

To estimate the engraftment rate for patients with CGD using busulfan, cyclophosphamide, fludarabine and alemtuzumab (Campath 1H) as conditioning therapy for SCT from 5/6 or 6/6 HLA-matched unrelated or 5/6 or 6/6 HLA phenotype-matched related donors.

Conditions Studied

Chronic Granulomatous Disease

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Cyclosporine
  • BIOLOGICAL Alemtuzumab

Study Locations (1)

Texas

  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2004-03
Est. Completion 2017-11-24
Phase Phase 2
Baylor College of Medicine

616 total trials

What the finished NCT00578643 record still lists

NCT00578643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 32-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (53% lower).

The record links to 1 condition, with Chronic Granulomatous Disease appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00578643 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT00578643 about?

NCT00578643 is a clinical study titled "Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease". This study is for patients with chronic granulomatous disease (CGD), which is a disorder of the immune system that puts them at risk for severe infections. CGD is caused by a genetic defect that stops or prevents the white blood cells from killing certain bacteria and fungi. This condition cannot pr...

What is the current status of trial NCT00578643?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2004-03. Estimated completion is 2017-11-24.

What conditions does trial NCT00578643 study?

This clinical trial studies the following conditions: Chronic Granulomatous Disease.

What interventions are being tested in trial NCT00578643?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Cyclosporine (DRUG), Alemtuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00578643?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00578643 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Granulomatous Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00578643's enrollment target sits among peer trials

15 8th of 10 higher than 3 of 10 other Chronic Granulomatous Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Granulomatous Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00578643, the US trial registry maintained by the National Library of Medicine. NCT00578643 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.