Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Myeloid Hematological Malignancies, sponsored by Baylor College of Medicine.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the overall survival rate at 1 year after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies.
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 |
What the finished NCT01247701 record still lists
NCT01247701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01247701's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia