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NCT01247701 · ClinicalTrials.gov registry record · NA
Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies
A NA study of Myeloid Hematological Malignancies, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01247701 is a NA study of Myeloid Hematological Malignancies that has completed, run by Baylor College of Medicine. The registered enrollment target is 16 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01247701, a NA study of Myeloid Hematological Malignancies, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an attempt to improve engraftment rate and reduce infections, the investigators are going to incorporate fludarabine in the conditioning regimen. The use of a BuCy backbone has been widely used and comparable to total body irradiation and cyclophosphamide (Cy/TBI) regimen. Encouraging data on adding fludarabine to the SCT regimen have been reported. A fludarabine-based, conditioning regimen, with adequate immunosuppressive activity could conceivably allow engraftment of stem cells from alternative donors in hematologic malignancies patients with acceptable engraftment rates and low transplant-related mortality. Regimen-related toxicity is believed to be a major contributing factor to GVHD. Therefore this approach may also lead to reduced GVHD, as some investigators have suggested. In an attempt to decrease the rate of viral infection and reactivation, the investigators will avoid ATG (Thymoglobulin) / Campath (anti-CD52), and instead administer Mycophenolate Mofetil (MMF). The addition of fludarabine should compensate any increase risk of graft failure with the removal of the ATG/Campath. The investigators anticipate that the removal of ATG/Campath will facilitate immune reconstitution more efficiently after receiving a UCBT.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- PROCEDURE Cord Blood Stem Cell Infusion
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-11 |
| Est. Completion | 2019-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01247701
The ClinicalTrials.gov registry entry for NCT01247701 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myeloid Hematological Malignancies appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01247701 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01247701 about?
NCT01247701 is a clinical study titled "Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies". In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an attempt to improve engraftment rate and reduce infections, the investigators are going to incorporate fludarabine in t...
What is the current status of trial NCT01247701?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2010-11. Estimated completion is 2019-10.
What conditions does trial NCT01247701 study?
This clinical trial studies the following conditions: Myeloid Hematological Malignancies.
What interventions are being tested in trial NCT01247701?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Cord Blood Stem Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01247701?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01247701 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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