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NCT00004997 · ClinicalTrials.gov registry record · Phase 2

Leucovorin for the Treatment of 5 q Minus Syndrome

A Phase 2 study of Myelodysplastic Syndrome and 5q Minus Syndrome, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
Phase 2
Development phase
14
Enrollment target
1
Study location

NCT00004997 is a Phase 2 study of Myelodysplastic Syndrome and 5q Minus Syndrome that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 14 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00004997, a Phase 2 study of Myelodysplastic Syndrome and 5q Minus Syndrome, has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

The 5 q minus syndrome is a condition that occurs due to a missing segment of chromosome 5 in the normal genetic make-up of the cells responsible for forming blood cells. The condition causes patients to have the inability to make blood normally. Many patients with this syndrome need transfusions of red blood cells, platelets, and/or white blood cells. Low levels of platelets may cause the patient to bleed easily and low levels of whit blood cells make the patient susceptible to infections. A small number of patients with 5 q minus syndrome develop leukemia, which is often untreatable with chemotherapy. Researchers believe that one of the genes missing in 5 q minus syndrome is the gene responsible for making folic acid active in the body. Folic acid is a vitamin required for normal blood production. The purpose of this study to test the effectiveness of a drug called leucovorin for the treatment of 5 q minus syndrome. Leucovorin is an active form of the vitamin folic acid that does not require the missing genes to activate it. Patients participating in this study may or may not improve with leucovorin treatment. However, the study will improve researchers understanding of the disease and may lead other potential therapies for the disease.

Interventions

  • DRUG Leucovorin

Study Locations (1)

Maryland

  • Warren G. Magnuson Clinical Center (CC) - Bethesda

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 1998-04
Est. Completion 2002-07
Phase Phase 2

What the Registry Record Tells You About NCT00004997

The ClinicalTrials.gov registry entry for NCT00004997 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (93% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Leucovorin is the first listed.

NCT00004997 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00004997 about?

NCT00004997 is a clinical study titled "Leucovorin for the Treatment of 5 q Minus Syndrome". The 5 q minus syndrome is a condition that occurs due to a missing segment of chromosome 5 in the normal genetic make-up of the cells responsible for forming blood cells. The condition causes patients to have the inability to make blood normally. Many patients with this syndrome need transfusions of...

What is the current status of trial NCT00004997?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 1998-04. Estimated completion is 2002-07.

What conditions does trial NCT00004997 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome, 5q Minus Syndrome.

What interventions are being tested in trial NCT00004997?

The interventions under investigation include: Leucovorin (DRUG).

Who is sponsoring clinical trial NCT00004997?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00004997 being conducted?

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

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