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NCT01471067 · ClinicalTrials.gov registry record · Phase 1
Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01471067: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01471067 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471067, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if it is safe and feasible to transplant changed cord blood for patients with leukemia or lymphoma. Researchers also want to learn if this can help to control the disease. The cord blood will be changed to make use of sugar that is found in small amounts in blood cells. It plays a role in signaling where in the body the transplanted cells should go to. Adding more sugars to the cord blood cells in the laboratory is designed to help the cord blood cells find their way faster to the bone marrow. This may help your blood counts to recover faster. This process is called fucosylation. Anti-thymocyte globulin (ATG) is a protein that removes immune cells that cause damage to the body. Clofarabine is designed to interfere with the growth and development of cancer cells. Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. This chemotherapy is also designed to block your body's ability to reject the donor's bone marrow cells. Melphalan and busulfan are designed to bind to the DNA of cells, which may cause cancer cells to die. Mycophenolate mofetil (MMF) and tacrolimus are designed to block the donor cells from growing and spreading in a way that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue attacks the recipient's body). This may help to prevent GVHD. Rituximab is designed to attach to cancer cells, which may cause them to die.
Primary Outcome
Engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Tacrolimus
- DRUG Mycophenolate mofetil
- PROCEDURE Cord Blood Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-07-13 |
| Est. Completion | 2017-04-25 |
| Phase | Phase 1 |
What the finished NCT01471067 record still lists
NCT01471067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01471067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01471067 about?
NCT01471067 is a clinical study titled "Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies". The goal of this clinical research study is to learn if it is safe and feasible to transplant changed cord blood for patients with leukemia or lymphoma. Researchers also want to learn if this can help to control the disease. The cord blood will be changed to make use of sugar that is found in small...
What is the current status of trial NCT01471067?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2012-07-13. Estimated completion is 2017-04-25.
What interventions are being tested in trial NCT01471067?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Tacrolimus (DRUG), Mycophenolate mofetil (DRUG), Cord Blood Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01471067?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01471067's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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