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NCT00923364 · ClinicalTrials.gov registry record · Phase 2
Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for MonoMAC
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00923364: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00923364 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923364, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
Background: * Stem cells are immature blood cells that grow in the bone marrow and produce all of the cells needed for normal blood and immunity. Stem cells can be taken from one person (donor) and given to another person (recipient) through allogeneic stem cell transplantation. Donor stem cells can then replace the recipients stem cells in the bone marrow, restoring normal blood production and immunity. Most allogeneic transplants now use stem cells collected from the donors blood in a process called peripheral blood stem cell transplantation. * Monocytopenia and mycobacterial infection (MonoMAC) is an immunodeficiency disease that is characterized by a lack of monocytes, a type of white blood cell, and an increased risk of developing mycobacteria infections that may cause tuberculosis. * Allogeneic stem cell transplantation has been used successfully to treat many kinds of immune diseases and cancers that develop in blood or immune system cells. Researchers have been studying a particular kind of stem cell transplantation that uses lower than usual doses of chemotherapy and particular combinations of drugs to improve the results of the procedure for patients with blood-related cancers and pre-cancerous conditions. Objectives: * To determine the safety and efficacy of reduced-intensity hematopoietic stem cell transplants (a particular stem cell transplantation procedure) for treating MonoMAC. Eligibility: * Patients 18-60 years of age who have MonoMAC and who have been matched with a suitable stem cell donor. Design: * Donors and recipients will undergo separate procedures as part of this protocol. * Donors: * National Institutes of Health researchers will take the donor s medical history, perform a physical exam, take blood samples, and explain the procedure. Tests will be performed to check the donors heart, lung, kidney, and liver function. * Donors will receive injections of a drug called filgrastim (G-CSF), which causes stem cells to travel from bone ma
Interventions
- DRUG Cyclophosphamide (CTX, Cytoxan)
- PROCEDURE Total Body Irradiation (TBI)
- DRUG Fludarabine(Fludara,Berlex Laboratories)
- PROCEDURE Allogeneic Hematopoietic Stem Cell (HSC)
- DRUG Equine Anti-Thymocyte Globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-05-07 |
| Est. Completion | 2017-02-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923364
The ClinicalTrials.gov registry entry for NCT00923364 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide (CTX, Cytoxan) is the first listed.
NCT00923364 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923364 about?
NCT00923364 is a clinical study titled "Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for MonoMAC". Background: * Stem cells are immature blood cells that grow in the bone marrow and produce all of the cells needed for normal blood and immunity. Stem cells can be taken from one person (donor) and given to another person (recipient) through allogeneic stem cell transplantation. Donor stem cells ca...
What is the current status of trial NCT00923364?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2009-05-07. Estimated completion is 2017-02-26.
What interventions are being tested in trial NCT00923364?
The interventions under investigation include: Cyclophosphamide (CTX, Cytoxan) (DRUG), Total Body Irradiation (TBI) (PROCEDURE), Fludarabine(Fludara,Berlex Laboratories) (DRUG), Allogeneic Hematopoietic Stem Cell (HSC) (PROCEDURE), Equine Anti-Thymocyte Globulin (DRUG).
Who is sponsoring clinical trial NCT00923364?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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