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NCT00606437 · ClinicalTrials.gov registry record · Phase 1

Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants

A Phase 1 study of Lymphoma and Leukemia, sponsored by Duke University.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
1
Study location

NCT00606437 is a Phase 1 study of Lymphoma and Leukemia that has completed, run by Duke University. The registered enrollment target is 40 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00606437, a Phase 1 study of Lymphoma and Leukemia, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

Results to date of umbilical cord blood transplantation in adult and fully mature adolescent patients are inferior to what is seen in children, due to a lower stem cell dosage in adults and a more toxic conditioning regimen. This phase 1 protocol will use a potentially less toxic bone marrow conditioning regimen, followed by infusion of a combined umbilical cord blood graft that will provide the patient with a higher stem cell dose than can be given with a single umbilical cord blood infusion. The subjects will be conditioned with a total body irradiation (TBI) 13.5 Gy and fludarabine. Following conditioning, up to two unrelated, partially matched umbilical cord blood grafts will be infused that will provide a minimum nucleated cell dose of 3 x 10e7/kg . The primary objective of this study is to measure the frequency of treatment-related toxicity and engraftment.

Interventions

  • PROCEDURE Total Body Irradiation with Fludarabine in UCB Transplants

Study Locations (1)

North Carolina

  • Duke University Health System - Durham

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2005-09
Est. Completion 2014-02
Phase Phase 1

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT00606437

The ClinicalTrials.gov registry entry for NCT00606437 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Total Body Irradiation with Fludarabine in UCB Transplants is the first listed.

NCT00606437 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00606437 about?

NCT00606437 is a clinical study titled "Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants". Results to date of umbilical cord blood transplantation in adult and fully mature adolescent patients are inferior to what is seen in children, due to a lower stem cell dosage in adults and a more toxic conditioning regimen. This phase 1 protocol will use a potentially less toxic bone marrow conditi...

What is the current status of trial NCT00606437?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2005-09. Estimated completion is 2014-02.

What conditions does trial NCT00606437 study?

This clinical trial studies the following conditions: Lymphoma, Leukemia, Solid Tumors, Myelofibrosis, Myeloma.

What interventions are being tested in trial NCT00606437?

The interventions under investigation include: Total Body Irradiation with Fludarabine in UCB Transplants (PROCEDURE).

Who is sponsoring clinical trial NCT00606437?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00606437 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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