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NCT00608517 · ClinicalTrials.gov registry record · NA

Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil

A NA study, sponsored by Vanderbilt-Ingram Cancer Center.

Terminated
Registry status
NA
Development phase
6
Enrollment target

NCT00608517: Clinical Trial NA study, sponsored by Vanderbilt-Ingram Cancer Center.

NCT00608517 is a NA study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00608517, a NA study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.

TERMINATED
Registry status
NA
Development phase
6 participants
Enrollment target

Study Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: To look at the ability of umbilical cord blood cells from one or two unrelated donors to serve as a source of stem cells for people needing a bone marrow transplant.

Primary Outcome

Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).

Interventions

  • DRUG cyclophosphamide
  • DRUG methylprednisolone
  • DRUG fludarabine phosphate
  • BIOLOGICAL anti-thymocyte globulin
  • RADIATION total-body irradiation

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2005-09
Est. Completion 2011-05
Phase NA
Vanderbilt-Ingram Cancer Center

189 total trials

Why NCT00608517 stopped before completion

NCT00608517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00608517 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00608517 about?

NCT00608517 is a clinical study titled "Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil". RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the ...

What is the current status of trial NCT00608517?

This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2005-09. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00608517?

The interventions under investigation include: cyclophosphamide (DRUG), methylprednisolone (DRUG), fludarabine phosphate (DRUG), anti-thymocyte globulin (BIOLOGICAL), total-body irradiation (RADIATION).

Who is sponsoring clinical trial NCT00608517?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00608517's enrollment target sits among peer trials

6 1983rd of 2000 higher than 13 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

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Source: ClinicalTrials.gov NCT00608517, the US trial registry maintained by the National Library of Medicine. NCT00608517 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.